No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00888912402996 | 79977 | KIT HIVOLT PROBE | IPF | Stimulator, muscle, powered | 2 | CHATTANOOGA | |
2 | 00888912022330 | 3013 | BARIATRC VF DISP CLF CF ASY PR | JOW | SLEEVE, LIMB, COMPRESSIBLE | 2 | AIRCAST | |
3 | 00888912008549 | 11B01 | LARGE KNEE CUFF ONLY | ILO | Pack, hot or cold, water circulating | 2 | AIRCAST | |
4 | 00888912006675 | 11-1522 | ICEMAN, ANKLE COLD PAD | ILO | Pack, hot or cold, water circulating | 2 | DONJOY | |
5 | 00190446703457 | 88-040000048494 | XTender Long | ITQ | JOINT, KNEE, EXTERNAL BRACE | 1 | NON FRANCHISE | |
6 | 00888912025362 | 78046 | APPLICATOR 10CM ASSY | IMI | Ultrasonic diathermy for use in applying therapeutic deep heat | 2 | CHATTANOOGA | |
7 | 00888912348669 | 4767 | KIT TRITON DTS PKG INT'L STD | ITH | EQUIPMENT, TRACTION, POWERED | 2 | CHATTANOOGA | |
8 | 00888912292122 | 27376 | KIT LEAD 2CH EPR | IKD | CABLE, ELECTRODE | 2 | CHATTANOOGA | |
9 | 00888912022460 | 30A | VENAFLOW SYSTEM | JOW | SLEEVE, LIMB, COMPRESSIBLE | 2 | AIRCAST | |
10 | 00888912000154 | 1033 | THERATHERM MOISTHEAT PAD SHLDR | IRT | PAD, HEATING, POWERED | 2 | CHATTANOOGA | |
11 | 00190446660330 | 155-79-84027 | ARM SLING, CTN/POLY LG | ILI | SLING, ARM | 1 | PROCARE | |
12 | 00190446660323 | 155-79-84025 | ARM SLING, CTN/POLY MED | ILI | SLING, ARM | 1 | PROCARE | |
13 | 00190446660316 | 155-79-84023 | ARM SLING, CTN/POLY SM | ILI | SLING, ARM | 1 | PROCARE | |
14 | 00190446660309 | 155-79-84022 | ARM SLING, CTN/POLY XSM | ILI | SLING, ARM | 1 | PROCARE | |
15 | 00190446714033 | 88-814000004021 | U2 WRIST UNIV LT | ITQ | JOINT, KNEE, EXTERNAL BRACE | 1 | NON FRANCHISE | |
16 | 00888912026932 | 79-80090 | 16 CKD KNEE IMMOBILIZER | MHW | Dressing, compression | 1 | PROCARE | |
17 | 00888912026321 | 79-72273 | PRO HEEL CUPS/PAIR - SMALL | KYS | INSOLES, MEDICAL | 1 | PROCARE | |
18 | 00190446708223 | 88-578000370513 | WRIST/HAND ORTHOSIS, BLK, L LT | ITQ | JOINT, KNEE, EXTERNAL BRACE | 1 | NON FRANCHISE | |
19 | 00190446708216 | 88-578000370512 | WRIST/HAND ORTHOSIS, BLK, M LT | ITQ | JOINT, KNEE, EXTERNAL BRACE | 1 | NON FRANCHISE | |
20 | 00190446708209 | 88-578000370511 | WRIST/HAND ORTHOSIS, BLK, S LT | ITQ | JOINT, KNEE, EXTERNAL BRACE | 1 | NON FRANCHISE | |
21 | 00190446708155 | 88-578000370501 | WRIST/HAND ORTHOSIS, BLK, S RT | ITQ | JOINT, KNEE, EXTERNAL BRACE | 1 | NON FRANCHISE | |
22 | 00190446707783 | 88-578000370534 | Wrist Hand Thumb Orthosis XL LT | ITQ | JOINT, KNEE, EXTERNAL BRACE | 1 | NON FRANCHISE | |
23 | 00190446707745 | 88-578000370530 | Wrist Hand Thumb Orthosis XS LT | ITQ | JOINT, KNEE, EXTERNAL BRACE | 1 | NON FRANCHISE | |
24 | 00190446707691 | 88-578000370520 | Wrist Hand Thumb Orthosis XS RT | ITQ | JOINT, KNEE, EXTERNAL BRACE | 1 | NON FRANCHISE | |
25 | 00190446707417 | 88-578000372071 | Ulnar Splint S | ITQ | JOINT, KNEE, EXTERNAL BRACE | 1 | NON FRANCHISE | |
26 | 00190446662709 | 155-79-81235 | SHOE, POST-OP SQ TOE MED | KNP | ORTHOSIS, CORRECTIVE SHOE | 1 | PROCARE | |
27 | 00190446662693 | 155-79-81233 | SHOE, POST-OP SQ TOE SM | KNP | ORTHOSIS, CORRECTIVE SHOE | 1 | PROCARE | |
28 | 00190446660552 | 155-79-96024 | KNEE IMMOBILIZER, XL 24 IN | ITQ | JOINT, KNEE, EXTERNAL BRACE | 1 | PROCARE | |
29 | 00190446660538 | 155-79-96019 | KNEE IMMOBILIZER, XL 20 IN | ITQ | JOINT, KNEE, EXTERNAL BRACE | 1 | PROCARE | |
30 | 00190446660521 | 155-79-96018 | KNEE IMMOBILIZER, XL 18 IN | ITQ | JOINT, KNEE, EXTERNAL BRACE | 1 | PROCARE | |
31 | 00190446660514 | 155-79-96016 | KNEE IMMOBILIZER, UNIV 16 IN | ITQ | JOINT, KNEE, EXTERNAL BRACE | 1 | PROCARE | |
32 | 00190446660507 | 155-79-96014 | KNEE IMMOBILIZER, UNIV 14 IN | ITQ | JOINT, KNEE, EXTERNAL BRACE | 1 | PROCARE | |
33 | 00190446660491 | 155-79-96012 | KNEE IMMOBILIZER, UNIV 12 IN | ITQ | JOINT, KNEE, EXTERNAL BRACE | 1 | PROCARE | |
34 | 00190446660347 | 155-79-84028 | ARM SLING, CTN/POLY XLG | ILI | SLING, ARM | 1 | PROCARE | |
35 | 00190446714224 | 88-004000041214 | CONFRMR I DIAB BOOT,1CUF,RT,XXL | ITQ | JOINT, KNEE, EXTERNAL BRACE | 1 | NON FRANCHISE | |
36 | 00190446714125 | 88-814000000019 | Universal Arm Sling with Foam Strap Adult | ITQ | JOINT, KNEE, EXTERNAL BRACE | 1 | NON FRANCHISE | |
37 | 00190446714040 | 88-814000004020 | U2 WRIST UNIV RT | ITQ | JOINT, KNEE, EXTERNAL BRACE | 1 | NON FRANCHISE | |
38 | 00190446713968 | 88-814000006295 | HKO ANTERIOR CLOSURE KNEE XL | ITQ | JOINT, KNEE, EXTERNAL BRACE | 1 | NON FRANCHISE | |
39 | 00190446713586 | 88-814000006293 | HKO ANTERIOR CLOSURE KNEE MD | ITQ | JOINT, KNEE, EXTERNAL BRACE | 1 | NON FRANCHISE | |
40 | 00190446713579 | 88-814000006292 | HKO ANTERIOR CLOSURE KNEE SM | ITQ | JOINT, KNEE, EXTERNAL BRACE | 1 | NON FRANCHISE | |
41 | 00190446713548 | 88-814008144803 | BAKER PLANTAR FASCIITIS NIGHT SPLINT, MEDIUM | ITQ | JOINT, KNEE, EXTERNAL BRACE | 1 | NON FRANCHISE | |
42 | 00190446713517 | 88-814008144802 | BAKER PLANTAR FASCIITIS NIGHT SPLINT, SMALL | ITQ | JOINT, KNEE, EXTERNAL BRACE | 1 | NON FRANCHISE | |
43 | 00190446707134 | 88-578000883065 | ELBOW SLEEVE W/PAD, 1/8, LARGE | ITQ | JOINT, KNEE, EXTERNAL BRACE | 1 | NON FRANCHISE | |
44 | 00190446707004 | 88-578000994303 | Soft Heel Cushions L | ITQ | JOINT, KNEE, EXTERNAL BRACE | 1 | NON FRANCHISE | |
45 | 00190446706991 | 88-578000994302 | Soft Heel Cushions M | ITQ | JOINT, KNEE, EXTERNAL BRACE | 1 | NON FRANCHISE | |
46 | 00190446706977 | 88-578000994301 | Soft Heel Cushions S | ITQ | JOINT, KNEE, EXTERNAL BRACE | 1 | NON FRANCHISE | |
47 | 00190446705888 | 88-578000372183 | MID LENGTH HUMERAL SPLINT, LARGE | ITQ | JOINT, KNEE, EXTERNAL BRACE | 1 | NON FRANCHISE | |
48 | 00190446705734 | 88-578000751015 | ANKLE STIRRUP W/AIR LINER BLK | ITQ | JOINT, KNEE, EXTERNAL BRACE | 1 | NON FRANCHISE | |
49 | 00190446705000 | 88-578000372163 | Extended Length Humeral Splint L | ITQ | JOINT, KNEE, EXTERNAL BRACE | 1 | NON FRANCHISE | |
50 | 00190446704997 | 88-578000372162 | Extended Length Humeral Splint M | ITQ | JOINT, KNEE, EXTERNAL BRACE | 1 | NON FRANCHISE |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 08809447652122 | Goggle ASSY (For patient) | Goggle ASSY (For patient) of HEALITE II / Rubber goggle | N/A | LUTRONIC CORPORATION | |
2 | 08809447651729 | Arm | Healite II Arm(Arn) | N/A | LUTRONIC CORPORATION | |
3 | 08809447651712 | Manual | Healite II Manual(Operator's Manual) | N/A | LUTRONIC CORPORATION | |
4 | 08809447651699 | Healite Body Assy | Healite Body Assy(System Main Body) | Healite II | LUTRONIC CORPORATION | |
5 | 08809447651675 | 830&590nm Head | Healite II 830&590nm Head (830/590nm head) | N/A | LUTRONIC CORPORATION | |
6 | 08800077100045 | D478000 | SMARTLUX MINI is the combination of low power beam irradiator and infrared irrad SMARTLUX MINI is the combination of low power beam irradiator and infrared irradiator, and it is KGMP, CE/MDD class IIa class medical equipment. Your attention to prevent danger or injury is required. Please read User’s Manual carefully before you use medical equipment, and if you have any questions on safety, application, or operation of the equipment, please contact MEDMIX Co., Ltd. or its distributor. | Medmix | MEDMIX CO., LTD. | |
7 | 08057949171645 | LUMIX C.P.S. 3 | LUMIXQ01 | LASER THERAPY UNIT LUMIX Q with 2 WAVELENGTH (650nm+1064nm) | LUMIX Q | FISIOLINE SRL |
8 | 08057949171553 | LUMIX ULTRA 2 | LULTRA1901HP | LASER THERAPY UNIT LUMIX ULTRA/PLUS with 4 WAVELENGTH (650nm+810nm+910nm+1064nm) LASER THERAPY UNIT LUMIX ULTRA/PLUS with 4 WAVELENGTH (650nm+810nm+910nm+1064nm) version HP | LUMIX ULTRA/PLUS | FISIOLINE SRL |
9 | 08057949170402 | LUMIX ULTRA 3 | LPLUS1602 | LASER THERAPY UNIT LUMIX ULTRA/PLUS with 4 WAVELENGTH (650nm+810nm+910nm+980nm) | LUMIX ULTRA/PLUS | FISIOLINE SRL |
10 | 08057949170396 | LUMIX ULTRA 2 | LPLUS1601 | LASER THERAPY UNIT LUMIX ULTRA/PLUS with 4 WAVELENGTH (650nm+810nm+910nm+1064nm) | LUMIX ULTRA/PLUS | FISIOLINE SRL |
11 | 08057949170389 | LUMIX ULTRA 1 | LPLUS13 | LASER THERAPY UNIT LUMIX ULTRA/PLUS with 3 WAVELENGTH (650nm+910mn+1064nm) | LUMIX ULTRA/PLUS | FISIOLINE SRL |
12 | 08057949170372 | LUMIX ULTRA 3 | LPLUS1002 | LASER THERAPY UNIT LUMIX ULTRA/PLUS with 3 WAVELENGTH (650nm+910nm+980nm) | LUMIX ULTRA/PLUS | FISIOLINE SRL |
13 | 08057949170365 | LUMIX ULTRA 1 | LPLUS1001 | LASER THERAPY UNIT LUMIX ULTRA/PLUS with 3 WAVELENGTH (650nm+910nm+1064nm) | LUMIX ULTRA/PLUS | FISIOLINE SRL |
14 | 08057949170358 | LUMIX ULTRA 1 | LULTRA35 | LASER THERAPY LUMIX ULTRA/PLUS with 3 WAVELENGTH (650nm+910nm+1064nm) | LUMIX ULTRA/PLUS | FISIOLINE SRL |
15 | 08057949170341 | LUMIX ULTRA 1 | LULTRA21 | LASER THERAPY UNIT LUMIX ULTRA/PLUS with 3 WAVELENGTH (650nm+910nm+1064nm) | LUMIX ULTRA/PLUS | FISIOLINE SRL |
16 | 08057949170334 | LUMIX ULTRA 3 | LULTRA1902 | LASER THERAPY UNIT LUMIX ULTRA/PLUS with 4 WAVELENGTH (650nm+810nm+910nm+980nm) | LUMIX ULTRA/PLUS | FISIOLINE SRL |
17 | 08057949170327 | LUMIX ULTRA 2 | LULTRA1901 | LASER THERAPY UNIT LUMIX ULTRA/PLUS with 4 WAVELENGTH (650nm+810nm+910nm+1064nm) | LUMIX ULTRA/PLUS | FISIOLINE SRL |
18 | 08057949170167 | LUMIX C.P.S.3 | LCPS31 | LASER THERAPY UNIT LUMIX C.P.S. with 3 WAVELENGTH (650nm+910nm+1064nm) | LUMIX C.P.S. | FISIOLINE SRL |
19 | 08057949170150 | LUMIX C.P.S.3 | LCPS17 | LASER THERAPY UNIT LUMIX C.P.S. with 3 WAVELENGTH (650nm+910nm+1064nm) | LUMIX C.P.S. | FISIOLINE SRL |
20 | 08057949170143 | LUMIX C.P.S.5 | LCPS1502 | LASER THERAPY UNIT LUMIX C.P.S. with 4 WAVELENGTH (650nm+810nm+910nm+1064nm) | LUMIX C.P.S. | FISIOLINE SRL |
21 | 08057949170136 | LUMIX C.P.S.4 | LCPS1501 | LASER THERAPY UNIT LUMIX C.P.S. with 4 WAVELENGTH (650nm+810nm+910nm+980nm) | LUMIX C.P.S. | FISIOLINE SRL |
22 | 08057949170129 | LUMIX C.P.S.3 | LCPS12 | LASER THERAPY UNIT LUMIX C.P.S. with 3 WAVELENGTH (650nm+910nm+1064nm) | LUMIX C.P.S. | FISIOLINE SRL |
23 | 08057949170112 | LUMIX C.P.S.3 | LCPS902 | LASER THERAPY UNIT LUMIX C.P.S. with 3 WAVELENGTH (650nm+910nm+1064nm) | LUMIX C.P.S. | FISIOLINE SRL |
24 | 08057949170105 | LUMIX C.P.S.2 | LCPS901 | LASER THERAPY UNIT LUMIX C.P.S. with 3 WAVELENGTH (650nm+910nm+980nm) | LUMIX C.P.S. | FISIOLINE SRL |
25 | 08057949170099 | LUMIX C.P.S.1 | LCPS702 | LASER THERAPY UNIT LUMIX C.P.S. with 3 WAVELENGTH (650nm+810nm+910nm) | LUMIX C.P.S. | FISIOLINE SRL |
26 | 08057949170082 | LUMIX C.P.S.4 | LCPS701 | LASER THERAPY UNIT LUMIX C.P.S. with 4 WAVELENGTH (650nm+810nm+910nm+980nm) | LUMIX C.P.S. | FISIOLINE SRL |
27 | 08057949170075 | LUMIX C.P.S.5 | LCPS6 | LASER THERAPY UNIT LUMIX C.P.S. with 4 WAVELENGTH (650nm+810nm+910nm+1064nm) | LUMIX C.P.S. | FISIOLINE SRL |
28 | 08057949170068 | LUMIX C.P.S.5 | LCPS5 | LASER THERAPY UNIT LUMIX C.P.S. with 4 WAVELENGTH (650nm+810nm+910nm+1064nm) | LUMIX C.P.S. | FISIOLINE SRL |
29 | 08057949170044 | LUMIX 250 | LUMIX250R2 | LASER THERAPY UNIT LUMIX 250 TOUCH SCREEN with 2 WAVELENGTH (650nm+910nm) AVERAGE POWER 5W | LUMIX 250 | FISIOLINE SRL |
30 | 08057949170037 | LUMIX 100 | LUMIX100R2 | LASER THERAPY UNIT LUMIX 100 TOUCH SCREEN with 2 WAVELENGTH (650nm+910nm) AVERAGE POWER 2W | LUMIX 100 | FISIOLINE SRL |
31 | 08057949170020 | LUMIX 2 | L2PC02 | LASER THERAPY UNIT LUMIX 2 with 2 WAVELENGTH | LUMIX 2 | FISIOLINE SRL |
32 | 08057949170013 | LUMIX 2 | L2PC01 | LASER THERAPY UNIT LUMIX 2 TOUCH SCREEN with 2 WAVELENGTH (650nm+910nm) | LUMIX 2 | FISIOLINE SRL |
33 | 08057017760498 | M120F1 | M120F1 | The PHYSIQ is a system provided with 4 IR LED to provide topical heating for the The PHYSIQ is a system provided with 4 IR LED to provide topical heating for the purpose of elevating tissue temperature for temporary relief of muscles.A LED mounted on top of each handpiece is lighted when the handpiece is emitting. | DEKA PHYSIQ | EL.EN. SPA |
34 | 08057017760214 | M080K1 | M080K1 | The ASA LASER HIRO 3.0 device is a medical device for carrying out therapy in th The ASA LASER HIRO 3.0 device is a medical device for carrying out therapy in the treatment of musculotendinous and joint pathologies with Nd:YAG Laser source. | DEKA HIRO 3.0 | EL.EN. SPA |
35 | 08057017760207 | M077H3 | M077H3 | The ASA LASER SH1 device is a medical device for carrying out therapy in the tre The ASA LASER SH1 device is a medical device for carrying out therapy in the treatment of musculotendinous and joint pathologies with Nd:YAG laser sources. | SH1 | EL.EN. SPA |
36 | 08033945934347 | PDMS00246 | Hyperblue plus | QUANTA SYSTEM SPA | ||
37 | 08033765391207 | F9000258 | The Mphi 7 is an electrically-powered diode laser intended to provide non-surgic The Mphi 7 is an electrically-powered diode laser intended to provide non-surgical infrared laser therapy for localized treatment of musculoskeletal conditions (e.g., muscle/joint pain, sports injury), improving blood circulation in the treated areas to facilitate healing, or for non-needle acupuncture. It consists of a control unit which may be mounted on a mobile trolley and one or more connected applicator to delivery of visible/infrared laser light energy. | Mphi 7 | ASA SRL | |
38 | 08033765391054 | F9000247 | M8 | ASA SRL | ||
39 | 08033765391023 | Mphi D | F9000235 | ASA srl | ASA SRL | |
40 | 08033765391016 | Mphi | F9000221 | ASA srl | ASA SRL | |
41 | 08033765391009 | M6 | F9000207 | ASA srl | ASA SRL | |
42 | 07290016746334 | VRE2003 | VRE2003 | FC Applicator | FC Applicator | VIORA LTD |
43 | 07290016746327 | VRE2002 | VRE2002 | BC Applicator | BC Applicator | VIORA LTD |
44 | 07290016746310 | VRE2001 | VRE2001 | ST Applicator | ST Applicator | VIORA LTD |
45 | 07290016746303 | VRE0110 | VRE0110 | Reaction™ | Reaction™ | VIORA LTD |
46 | 07290016681000 | FS10000 | FS10000 | Multi-modality system supporting IPL (Intense Pulsed Light), RF (Radio Frequency Multi-modality system supporting IPL (Intense Pulsed Light), RF (Radio Frequency) and Diamond Peeling applicators for various treatmentssuch as Hair Removal, Acne, Pigmented Lesions, Skin Dermabrasion | Forma | FORMATK SYSTEMS LTD |
47 | 06974746830013 | HK209 | NA | NINGBO HESI ELECTRONICS CO., LTD. | ||
48 | 06974746830006 | HK207 | NA | NINGBO HESI ELECTRONICS CO., LTD. | ||
49 | 06974214160192 | CHERYLAS-20N | Therapy Laser System, with Product Code of ILY, Regulation number of 890.5500, a Therapy Laser System, with Product Code of ILY, Regulation number of 890.5500, and exempt from 510(K) | Dimed | WUHAN DIMED LASER TECHNOLOGY CO., LTD. | |
50 | 06974214160185 | CHERYLAS-15N | Therapy Laser System, with Product Code of ILY, Regulation number of 890.5500, a Therapy Laser System, with Product Code of ILY, Regulation number of 890.5500, and exempt from 510(K) | Dimed | WUHAN DIMED LASER TECHNOLOGY CO., LTD. |