No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00815962020306 | ST2-SW01 | Clinician Programmer Software | GZF | STIMULATOR, PERIPHERAL NERVE, IMPLANTED (PAIN RELIEF) | 2 | StimRouter | |
2 | 00815962021464 | ST2-5050 | External Electrical Field Conductor | GZF | Stimulator, peripheral nerve, implanted (pain relief) | 2 | StimRouter User Kit | |
3 | 00815962020214 | BIT-2224 | Bioness Integrated Therapy System, Version 2.0, Mobile Configuration, 24" Displa Bioness Integrated Therapy System, Version 2.0, Mobile Configuration, 24" Display with Software | IKK | SYSTEM, ISOKINETIC TESTING AND EVALUATION | 2 | Bioness Integrated System (BITS) Mobile Configuration | |
4 | 00815962020122 | BIT-2124 | Bioness Integrated Therapy System, Version 2.0, Bedside Configuration, 24" Displ Bioness Integrated Therapy System, Version 2.0, Bedside Configuration, 24" Display with Software | IKK | SYSTEM, ISOKINETIC TESTING AND EVALUATION | 2 | Bioness Integrated System (BITS) Bedside Configuration | |
5 | 00815962020016 | ST2-1000 | StimRouter Implantable Lead | GZF | STIMULATOR, PERIPHERAL NERVE, IMPLANTED (PAIN RELIEF) | 2 | StimRouter Implantable Kit | |
6 | 00815962020030 | ST2-5000 | External Pulse Transmitter (EPT) | GZF | STIMULATOR, PERIPHERAL NERVE, IMPLANTED (PAIN RELIEF) | 2 | StimRouter User Kit | |
7 | 00815962020627 | BITS-3155 | BITS PC Kit, BITS Balance Accessory Kit, and BITS Balance Platform Kit | IKK,PTY,ISD | SYSTEM, ISOKINETIC TESTING AND EVALUATION,Computerized cognitive assessment aid, SYSTEM, ISOKINETIC TESTING AND EVALUATION,Computerized cognitive assessment aid, exempt,Exerciser, measuring | 2 | Bioness Integrated Therapy System, BITS 3.0, BITS Balance | |
8 | 00815962020399 | L4T-6000 | L360 Thigh System Kit, Right | GZI,IPF | STIMULATOR, NEUROMUSCULAR, EXTERNAL FUNCTIONAL,Stimulator, muscle, powered | 2 | L360 Thigh System | |
9 | 00815962020382 | L4T-6001 | L360 Thigh System Kit, Left | IPF,GZI | Stimulator, muscle, powered,STIMULATOR, NEUROMUSCULAR, EXTERNAL FUNCTIONAL | 2 | L360 Thigh System | |
10 | 00815962020344 | LG1-5X00 | L100 Go System, Left | GZI,IPF | STIMULATOR, NEUROMUSCULAR, EXTERNAL FUNCTIONAL,Stimulator, muscle, powered | 2 | L100 Go System | |
11 | 00815962020337 | LG1-5Y00 | L100 Go System, Right | GZI,IPF | STIMULATOR, NEUROMUSCULAR, EXTERNAL FUNCTIONAL,Stimulator, muscle, powered | 2 | L100 Go System | |
12 | 00815962020153 | L4P-5001 | L300 Go system with Left Thigh cuff | IPF,GZI | Stimulator, muscle, powered,STIMULATOR, NEUROMUSCULAR, EXTERNAL FUNCTIONAL | 2 | L300 Go System, Left Thigh Plus | |
13 | 07290110483036 | L3P-5100 | 501-00127-01 | L300 Plus US Upgrade System Kit, Right (regular) | IPF | Stimulator, muscle, powered | 2 | NESS L300-Plus System |
14 | 07290110483043 | L3P-4100 | 501-00046-01 | L300 Plus US Clinician's Upgrade Kit | IPF | Stimulator, muscle, powered | 2 | NESS L300-Plus System |
15 | 07290110483029 | L3P-5101 | 501-00126-01 | L300 Plus US Upgrade System Kit, Left (regular) | IPF | Stimulator, muscle, powered | 2 | NESS L300-Plus System |
16 | 07290110483012 | L3P-5000 | 501-00123-01 | L300 Plus US System Kit, Right (regular) | IPF | Stimulator, muscle, powered | 2 | NESS L300-Plus System |
17 | 07290110483005 | L3P-5001 | 501-00122-01 | L300 Plus US System Kit, Left (regular) | IPF | Stimulator, muscle, powered | 2 | NESS L300-Plus System |
18 | 07290110482084 | H2W-4700 | 501-00176-01 | H200 Wireless US Clinician Upgrade Kit | IPF | Stimulator, muscle, powered | 2 | NESS H200® Wireless Hand Rehabilitation System |
19 | 07290110482077 | H2W-5000 | 501-00121-01 | H200 Wireless US System kit, Left Small | IPF | Stimulator, muscle, powered | 2 | NESS H200® Wireless Hand Rehabilitation System |
20 | 07290110482060 | H2W-5100 | 501-00120-01 | H200 Wireless US System kit, Right Small | IPF | Stimulator, muscle, powered | 2 | NESS H200® Wireless Hand Rehabilitation System |
21 | 07290110482053 | H2W-4100 | 501-00095-01 | H200 Wireless US Clinician Kit Large | IPF | Stimulator, muscle, powered | 2 | NESS H200® Wireless Hand Rehabilitation System |
22 | 07290110482046 | H2W-4000 | 501-00094-01 | H200 Wireless (US) Clinician Kit, Small / Medium | IPF | Stimulator, muscle, powered | 2 | NESS H200® Wireless Hand Rehabilitation System |
23 | 07290110482039 | H2W-5400 | 501-00042-01 | H200 Wireless US System Kit, Left Large | IPF | Stimulator, muscle, powered | 2 | NESS H200® Wireless Hand Rehabilitation System |
24 | 07290110482022 | H2W-5500 | 501-00041-01 | H200 Wireless US System Kit, Right Large | IPF | Stimulator, muscle, powered | 2 | NESS H200® Wireless Hand Rehabilitation System |
25 | 07290110482015 | H2W-5200 | 501-00038-01 | H200 Wireless US System kit, Left Medium | IPF | Stimulator, muscle, powered | 2 | NESS H200® Wireless Hand Rehabilitation System |
26 | 07290110482008 | H2W-5300 | 501-00037-01 | H200 Wireless US System kit, Right Medium | IPF | Stimulator, muscle, powered | 2 | NESS H200® Wireless Hand Rehabilitation System |
27 | 00815962020276 | VEC-1100 | Vector Trolley Assembly, Elite Model | BXB | EXERCISER, POWERED | 1 | Vector Elite | |
28 | 00815962020269 | VEC-1000 | Vector Gait and Safety System | BXB | EXERCISER, POWERED | 1 | Vector Elite | |
29 | 07290110483098 | LG3-5U00 | 501-00170-01 | Small L300 System Kit, Right US | IPF | Stimulator, muscle, powered | 2 | NESS L300 Foot Drop System |
30 | 07290110483081 | LG3-5V00 | 501-00169-01 | Small L300 System Kit, Left US | IPF | Stimulator, muscle, powered | 2 | NESS L300 Foot Drop System |
31 | 07290110483074 | LG3-4000 | 501-00161-01 | Regular L300 Clinician's Kit US | IPF | Stimulator, muscle, powered | 2 | NESS L300 Foot Drop System |
32 | 07290110483067 | LG3-5000 | 501-00159-01 | Regular L300 System Kit, Right US | IPF | Stimulator, muscle, powered | 2 | NESS L300 Foot Drop System |
33 | 07290110483050 | LG3-5100 | 501-00158-01 | Regular L300 System Kit, Left US | IPF | Stimulator, muscle, powered | 2 | NESS L300 Foot Drop System |
34 | 00815962020054 | 2.0.1 | IKK | SYSTEM, ISOKINETIC TESTING AND EVALUATION | 2 | Bioness Integrated System (BITS)2.0.5 | ||
35 | 00815962020245 | 2.0.5 | Bioness Integrated Therapy Software | IKK | SYSTEM, ISOKINETIC TESTING AND EVALUATION | 2 | Bioness Integrated System (BITS)2.0.5 | |
36 | 00815962020238 | BIT-2048 | Bioness Integrated Therapy System, Version 2.0, 48" Display with Software | IKK | SYSTEM, ISOKINETIC TESTING AND EVALUATION | 2 | Bioness Integrated System (BITS)2.0.5 | |
37 | 00815962020221 | BIT-2055 | Bioness Integrated Therapy System, Version 2.0, 55" Display with Software | IKK | SYSTEM, ISOKINETIC TESTING AND EVALUATION | 2 | Bioness Integrated System (BITS)2.0.5 | |
38 | 00815962020160 | L4T-5001 | L300 Go system with Left Thigh cuff only | GZI,IPF | STIMULATOR, NEUROMUSCULAR, EXTERNAL FUNCTIONAL,Stimulator, muscle, powered | 2 | L300 Go System, Left Thigh Stand-Alone | |
39 | 00815962020146 | LG4-5V00 | L300 Go system with Small Left cuff | GZI,IPF | STIMULATOR, NEUROMUSCULAR, EXTERNAL FUNCTIONAL,Stimulator, muscle, powered | 2 | L300 Go System, Left Small Lower Leg | |
40 | 00815962020603 | H2W-4700 | H200 Wireless Clinician Upgrade Kit | GZI | STIMULATOR, NEUROMUSCULAR, EXTERNAL FUNCTIONAL | 2 | H200 Wireless System | |
41 | 00815962020597 | H2W-5000 | H200 Wireless System Kit, Left (Small) | GZI | STIMULATOR, NEUROMUSCULAR, EXTERNAL FUNCTIONAL | 2 | H200 Wireless System | |
42 | 00815962020580 | H2W-5100 | H200 Wireless System Kit, Right (Small) | GZI | STIMULATOR, NEUROMUSCULAR, EXTERNAL FUNCTIONAL | 2 | H200 Wireless System | |
43 | 00815962020573 | H2W-4100 | H200 Wireless Clinician Kit, Large | GZI | STIMULATOR, NEUROMUSCULAR, EXTERNAL FUNCTIONAL | 2 | H200 Wireless System | |
44 | 00815962020566 | H2W-4000 | H200 Wireless Clinician Kit, Small / Medium | GZI | STIMULATOR, NEUROMUSCULAR, EXTERNAL FUNCTIONAL | 2 | H200 Wireless System | |
45 | 00815962020559 | H2W-5400 | H200 Wireless System Kit, Left (Large) | GZI | STIMULATOR, NEUROMUSCULAR, EXTERNAL FUNCTIONAL | 2 | H200 Wireless System | |
46 | 00815962020542 | H2W-5500 | H200 Wireless System Kit, Right (Large) | GZI | STIMULATOR, NEUROMUSCULAR, EXTERNAL FUNCTIONAL | 2 | H200 Wireless System | |
47 | 00815962020535 | H2W-5200 | H200 Wireless System Kit, Left (Medium) | GZI | STIMULATOR, NEUROMUSCULAR, EXTERNAL FUNCTIONAL | 2 | H200 Wireless System | |
48 | 00815962020528 | H2W-5300 | H200 Wireless System Kit, Right (Medium) | GZI | STIMULATOR, NEUROMUSCULAR, EXTERNAL FUNCTIONAL | 2 | H200 Wireless System | |
49 | 00815962020511 | H2W-5D00 | Cloth Electrodes Set | GZI,IPF | STIMULATOR, NEUROMUSCULAR, EXTERNAL FUNCTIONAL,Stimulator, muscle, powered | 2 | H200 Wireless System | |
50 | 00815962020184 | LG4-5U00 | L300 Go system with Small Right cuff | IPF,GZI | Stimulator, muscle, powered,STIMULATOR, NEUROMUSCULAR, EXTERNAL FUNCTIONAL | 2 | L300 Go System, Right Small Lower Leg |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 00190446293613 | 13-4024 | MOTION INTELLIGENCE APP | RAW MATERIAL | DJO, LLC | |
2 | 00190446286974 | 11-4001-0-06000 | X4 KNEE BRACE, LT, UNIV, BLK | DONJOY | DJO, LLC | |
3 | 00190446286967 | 11-4000-0-06000 | X4 KNEE BRACE, RT, UNIV, BLK | DONJOY | DJO, LLC | |
4 | B654LS0 | LEGSys | LEGSys™ is a wireless wearable system based on 9 degree-of-freedom inertial meas LEGSys™ is a wireless wearable system based on 9 degree-of-freedom inertial measurement sensors. LEGSys™ is intended for measuring spatiotemporal parameters of gait based on the joint angles of the lower limbs during human walking over ground or on a treadmill. Additionally for patients aged 70 and up, LEGSys™ is intended to assess a patient’s risk of falling based on measured spatiotemporal parameters of gait and published, publicly available, scientific data regarding fall risk. | LEGSys | BIOSENSICS LLC | |
5 | B628OPALV2C0 | V2C | OPALV2C | APDM's Opal V2C is a small worn monitor designed for documenting physical moveme APDM's Opal V2C is a small worn monitor designed for documenting physical movement associated with applications in physiological monitoring. The Opal V2C can be used in any instance where quantifiable analysis of physical motion is desirable. | Opal V2C | APDM, INC. |
6 | B628DSV2C0 | V2C | DSV2C | APDM’s Docking Station is an accessory that transfers the raw sensor data logged APDM’s Docking Station is an accessory that transfers the raw sensor data logged to a computer for the Opal V2C. Additionally, the Docking Station recharges the battery of an Opal V2C. | Docking Station V2C | APDM, INC. |
7 | B628APV2C0 | V2C | APV2C | APDM’s Access Point is an accessory that enables wireless streaming to a compute APDM’s Access Point is an accessory that enables wireless streaming to a computer for the Opal V2C. | Access Point V2C | APDM, INC. |
8 | B626200020 | 20002 | Research Platform | LINUS HEALTH, INC. | ||
9 | B626200010 | 20001 | 20001 | Core Cognitive Evaluation is a non-invasive test that assess possible cognitive Core Cognitive Evaluation is a non-invasive test that assess possible cognitive impairment. It is intended to be used by medical professionals qualified to interpret results of a cognitive assessment. | Core Cognitive Evaluation | LINUS HEALTH, INC. |
10 | B62611100 | 1110 | 1110 | DCTclock System | DCTclock | LINUS HEALTH, INC. |
11 | B626100960 | 10096 | 10096 | DCTclock System - Research | DCTclock | LINUS HEALTH, INC. |
12 | B626100930 | 10093 | 10093 | DCTclock Practice Test Form - clinical | DCTclock | LINUS HEALTH, INC. |
13 | B626100720 | 10072 | 10072 | DCTclock Test Form - Clinical | DCTclock | LINUS HEALTH, INC. |
14 | B626100410 | 10041 | 10041 | DCTclock Uploader Software | DCTclock | LINUS HEALTH, INC. |
15 | B626100390 | 10039 | 10039 | DCTclock Practice Test Form - Research | DCTclock | LINUS HEALTH, INC. |
16 | B626100150 | 10015 | 10015 | DCTclock Cloud Platform | DCTclock | LINUS HEALTH, INC. |
17 | B626100060 | 10006 | 10006 | DCTclock Micro USB Cable | DCTclock | LINUS HEALTH, INC. |
18 | B626100050 | 10005 | 10005 | DCTclock Dock | DCTclock | LINUS HEALTH, INC. |
19 | B626100040 | 10004 | 10004 | DCTclock Digital Pen | DCTclock | LINUS HEALTH, INC. |
20 | B626100030 | 10003 | 10003 | DCTclock Test Form - Research | DCTclock | LINUS HEALTH, INC. |
21 | B534HUBER360MDUS1 | HUBER | HUBER | L P G SYSTEMS | ||
22 | B493SW0043 | SW-0043 | Web application | Kintinuum™ | MC10, INC. | |
23 | B493SW0042 | SW-0042 | Patient application for Android | Kintinuum™ | MC10, INC. | |
24 | B493MC0016 | MC-0016 | Instructions for use | Kintinuum™ | MC10, INC. | |
25 | B493MC0011 | MC-0011 | MC-0011 kit containing DIs B493BRCS02, B493BRCD02, B493BRCP03, B493BSPS01, B493B MC-0011 kit containing DIs B493BRCS02, B493BRCD02, B493BRCP03, B493BSPS01, B493BRCA05, B493MC0009 | Kintinuum™ | MC10, INC. | |
26 | 17540176010002 | RV10 | The ReJoyce is a rehabilitation device intended to increase the strength of musc The ReJoyce is a rehabilitation device intended to increase the strength of muscles and the range of motion of joints of the upper extremities.The ReJoyce helps patients to retrain and condition their muscles by using their hands and arms to play interactive computer games.The activities required by the computer games are similar to tasks used in everyday life, such as pouring a drink or opening a jar. Practicing these motions will help patients to replicate them in real life. | ReJoyce | REHABTRONICS INC | |
27 | 10850390007816 | LE1 | A recumbent, closed-chain exercise device that provides eccentric (negative) res A recumbent, closed-chain exercise device that provides eccentric (negative) resistance to lower extremity motion. It also measures strength and dynamic workload through its computer interface. | Eccentron | BTE TECHNOLOGIES, INC. | |
28 | 10850390007427 | MCU 2 | A rehabilitation device for neck strengthening exercises, as well as measurement A rehabilitation device for neck strengthening exercises, as well as measurement of cervical spine range of motion and strength. Neck musculoskeletal measurements can be taken for flexion, extension, lateral flexion, rotation, and for combined planes. | MCU Multi-Cervical Unit | BTE TECHNOLOGIES, INC. | |
29 | 10850390007380 | Prism1 | A rehabilitation system used to quantify muscle strength and range of motion, as A rehabilitation system used to quantify muscle strength and range of motion, as well as quantify compound physical abilities needed for the performance of functional tasks. | Prism | BTE TECHNOLOGIES, INC. | |
30 | 10850390007373 | Evaluator EV | A portable measurement system for quantifying musculoskeletal strength and range A portable measurement system for quantifying musculoskeletal strength and range of motion. Various EV versions are available that are different configurations of the same medical device model. | Evaluator | BTE TECHNOLOGIES, INC. | |
31 | 10850390007366 | Evaluator EVJ | A portable measurement system for quantifying musculoskeletal strength and range A portable measurement system for quantifying musculoskeletal strength and range of motion. | EVJ | BTE TECHNOLOGIES, INC. | |
32 | 10850390007359 | 1 | A rehabilitation system used to quantify muscle strength and range of motion, as A rehabilitation system used to quantify muscle strength and range of motion, as well as quantify compound physical abilities needed for the performance of functional tasks. | Provider Test Kit (PTK) | BTE TECHNOLOGIES, INC. | |
33 | 10850390007342 | EV2 | Evaluator EV2 | BTE TECHNOLOGIES, INC. | ||
34 | 10850390007335 | Evaluator | A portable measurement system for quantifying musculoskeletal strength and range A portable measurement system for quantifying musculoskeletal strength and range of motion. | Evaluator | BTE TECHNOLOGIES, INC. | |
35 | 10850390007328 | EvalTech | A rehabilitation system used to quantify muscle strength and range of motion, as A rehabilitation system used to quantify muscle strength and range of motion, as well as quantify compound physical abilities needed for the performance of functional tasks. | EvalTech | BTE TECHNOLOGIES, INC. | |
36 | 10850390007311 | ER | ER | BTE TECHNOLOGIES, INC. | ||
37 | 10850390007243 | PrimusRS | A very versatile rehabilitation device for upper extremity and lower extremity s A very versatile rehabilitation device for upper extremity and lower extremity strength testing and exercise. The dynamometer offers isometric, isotonic, isokinetic, eccentric, concentric, and continuous passive motion modes, as well as many adapters for isolated joint and compound motions. | PrimusRS | BTE TECHNOLOGIES, INC. | |
38 | 10850390007236 | Primus+ | A very versatile rehabilitation device for upper extremity and lower extremity s A very versatile rehabilitation device for upper extremity and lower extremity strength testing and exercise. The dynamometer offers isometric, isotonic, isokinetic, eccentric, concentric, and continuous passive motion modes, as well as many adapters for isolated joint and compound motions. | Primus | BTE TECHNOLOGIES, INC. | |
39 | 09120077180076 | R1 | The LEXO is a mechatronic therapy system for body weight-supported gait rehabili The LEXO is a mechatronic therapy system for body weight-supported gait rehabilitation of patients with a limited ability to walk. | LEXO | TYROMOTION GMBH | |
40 | 08800043810121 | MW-V100 | Morning Walk | CUREXO, INC. | ||
41 | 08800043810022 | MW-S200 | AC-00000-000 | MW-S200 | Morning Walk | CUREXO, INC. |
42 | 08717524641061 | 925909 | 965920 Excalibur Sport PFM | Lode B.V. | LODE B.V. | |
43 | 08717524641054 | 925900 | 965910 Excalibur Sport | Lode B.V. | LODE B.V. | |
44 | 08717524640712 | 969900 | 969900 Corival Recumbent cpet | Lode B.V. | LODE B.V. | |
45 | 08717524640705 | 969901 | 969901 Corival Recumbent rehab | Lode B.V. | LODE B.V. | |
46 | 08717524640699 | 960903 | 960903 Corival pediatric | Lode B.V. | LODE B.V. | |
47 | 08717524640620 | 967941 | 967941 Angio imaging - with stress support ultrasound (110V) | Lode B.V. | LODE B.V. | |
48 | 08717524640613 | 967940 | 967941 Angio imaging - with stress support ultrasound (110V) | Lode B.V. | LODE B.V. | |
49 | 08717524640576 | 967925 | 967925 Angio rehab fixation set | Lode B.V. | LODE B.V. | |
50 | 08717524640569 | 967924 | 967924 Angio rehab automatic stand | Lode B.V. | LODE B.V. |