No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | B108785APSMUS00 | SMALL applicator | GEI | Electrosurgical, Cutting & Coagulation & Accessories | 2 | SMALL applicator | ||
2 | B108A299AP13ENUS1000 | HPM-6000U Applicator Chair | KPI | Stimulator, Electrical, Non-Implantable, For Incontinence | 2 | HPM-6000U Applicator Chair | ||
3 | B108284AP01ENUS0100 | BTL-284-01 | PBX | Massager, Vacuum, Radio Frequency Induced Heat | 2 | BTL Unison applicator | ||
4 | B108284AP01EMTENUS0100 | BTL-284-01 | PBX | Massager, Vacuum, Radio Frequency Induced Heat | 2 | EMTONE applicator | ||
5 | B108215APSAUSNPTENUS0 | 215/2 | PBX | Massager, Vacuum, Radio Frequency Induced Heat | 2 | Exilis small applicator | ||
6 | B108585POMUS00 | BTL-585 | GEI | Electrosurgical, Cutting & Coagulation & Accessories | 2 | BTL-585 | ||
7 | B108785TIPVMUS00 | EMFEMME V tip | PBX | Massager, Vacuum, Radio Frequency Induced Heat | 2 | EMFEMME V tip | ||
8 | B108299AP26ENUS011020 | BTL-299-6 | NGX | Stimulator, Muscle, Powered, For Muscle Conditioning | 2 | BTL-299-6 | ||
9 | B108899AP2M3MUS00 | 899-AP-M-3 | KPI | Stimulator, Electrical, Non-Implantable, For Incontinence | 2 | BTL Chair Applicator | ||
10 | B108899AP2C45MUS00 | Edge applicator | GEI | Electrosurgical, Cutting & Coagulation & Accessories | 2 | Edge applicator | ||
11 | B108299AP26ENUS011010 | BTL-299-6 | NGX | Stimulator, Muscle, Powered, For Muscle Conditioning | 2 | BTL-299-6 | ||
12 | B108299AP26ENUS011000 | BTL-299-6 | NGX | Stimulator, Muscle, Powered, For Muscle Conditioning | 2 | BTL-299-6 | ||
13 | B108784POENUS0100 | BTL Unison | PBX | Massager, Vacuum, Radio Frequency Induced Heat | 2 | BTL Unison | ||
14 | B108A299AP13ENUS1020 | BTL Chair Applicator | KPI | Stimulator, Electrical, Non-Implantable, For Incontinence | 2 | BTL Chair Applicator | ||
15 | B108A299AP13ENUS1010 | BTL Chair Applicator | KPI | Stimulator, Electrical, Non-Implantable, For Incontinence | 2 | BTL Chair Applicator | ||
16 | B108216APIPLF1140US1020 | BTL Exilite handpiece | ONF | Powered Light Based Non-Laser Surgical Instrument With Thermal Effect | 2 | BTL Exilite handpiece | ||
17 | B108216APIPLF1140US0 | BTL Exilite handpiece | ONF | Powered Light Based Non-Laser Surgical Instrument With Thermal Effect | 2 | BTL Exilite handpiece | ||
18 | B108216APIPLF1140ENUS0 | BTL Exilite handpiece | ONF | Powered Light Based Non-Laser Surgical Instrument With Thermal Effect | 2 | BTL Exilite handpiece | ||
19 | B108215APLATENUS0 | 215/1 | GEI | Electrosurgical, Cutting & Coagulation & Accessories | 2 | Exilis large applicator | ||
20 | B108215APLAT0 | 215/1 | GEI | Electrosurgical, Cutting & Coagulation & Accessories | 2 | Exilis large applicator | ||
21 | B108703POENUS0100 | BTL-703 | IMJ | Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat | 2 | BTL-703 | ||
22 | B108785TIPV24MUS00 | EMFEMME V24 tip | PBX | Massager, Vacuum, Radio Frequency Induced Heat | 2 | EMFEMME V24 tip | ||
23 | B108785APLMUS00 | LARGE applicator | GEI | Electrosurgical, Cutting & Coagulation & Accessories | 2 | LARGE applicator | ||
24 | B108299AP11ENUS1000 | BTL-299-1 | IPF | Stimulator, Muscle, Powered | 2 | BTL-299-1 | ||
25 | B108744POCTENUS1030 | BTL Cellutone | PBX | Massager, Vacuum, Radio Frequency Induced Heat | 2 | BTL Cellutone | ||
26 | B108744POCTENUS0 | BTL Cellutone | IRO | Vibrator, Therapeutic | 1 | BTL Cellutone | ||
27 | B108899PO11C1ENUS0110 | EMSCULPT NEO | GEI | Electrosurgical, Cutting & Coagulation & Accessories | 2 | EMSCULPT NEO | ||
28 | B108899PO11C1ENUS0100 | EMSCULPT NEO | GEI | Electrosurgical, Cutting & Coagulation & Accessories | 2 | EMSCULPT NEO | ||
29 | B108899APC1ENUS0130 | 899-AP-C-1 | GEI | Electrosurgical, Cutting & Coagulation & Accessories | 2 | Large applicator | ||
30 | B108899APC1ENUS0120 | 899-AP-C-1 | GEI | Electrosurgical, Cutting & Coagulation & Accessories | 2 | Large applicator | ||
31 | B108899APC1ENUS0110 | 899-AP-C-1 | GEI | Electrosurgical, Cutting & Coagulation & Accessories | 2 | Large applicator | ||
32 | B108899APC1ENUS0100 | 899-AP-C-1 | GEI | Electrosurgical, Cutting & Coagulation & Accessories | 2 | Large applicator | ||
33 | B108785APMMUS00 | BTL-785-7 | PBX,GEI | Massager, Vacuum, Radio Frequency Induced Heat,Electrosurgical, Cutting & Coagul Massager, Vacuum, Radio Frequency Induced Heat,Electrosurgical, Cutting & Coagulation & Accessories | 2 | EMFACE controller | ||
34 | B108784POEMTENUS0100 | EMTONE | PBX | Massager, Vacuum, Radio Frequency Induced Heat | 2 | EMTONE | ||
35 | B108D099PO130ENUS1010 | HPM-6000U | KPI | Stimulator, Electrical, Non-Implantable, For Incontinence | 2 | HPM-6000U | ||
36 | B108D099PO130ENUS1000 | HPM-6000U | KPI | Stimulator, Electrical, Non-Implantable, For Incontinence | 2 | HPM-6000U | ||
37 | B108899PO11C1ENUS0130 | EMSCULPT NEO | GEI | Electrosurgical, Cutting & Coagulation & Accessories | 2 | EMSCULPT NEO | ||
38 | B108899PO11C1ENUS0120 | EMSCULPT NEO | GEI | Electrosurgical, Cutting & Coagulation & Accessories | 2 | EMSCULPT NEO | ||
39 | B108D099PO130ENUS1030 | BTL EMSELLA | KPI | Stimulator, Electrical, Non-Implantable, For Incontinence | 2 | BTL EMSELLA | ||
40 | B108799PO121ENUS1000 | HPM-6000 | IPF | Stimulator, Muscle, Powered | 2 | HPM-6000 | ||
41 | B108299AP27ENUS0100 | BTL-299-7 | NGX | Stimulator, Muscle, Powered, For Muscle Conditioning | 2 | Small applicator | ||
42 | B108899AP2M2MUS00 | 899-AP-M-2 | NGX | Stimulator, Muscle, Powered, For Muscle Conditioning | 2 | Small applicator | ||
43 | B108899AP2C2MUS10 | 899-AP-C-2 | GEI | Electrosurgical, Cutting & Coagulation & Accessories | 2 | Small applicator | ||
44 | B108899AP2C2MUS00 | 899-AP-C-2 | NGX | Stimulator, Muscle, Powered, For Muscle Conditioning | 2 | Small applicator | ||
45 | B108799PO2166ENUS0130 | BTL EMSCULPT | NGX | Stimulator, Muscle, Powered, For Muscle Conditioning | 2 | BTL EMSCULPT | ||
46 | B108799PO2166ENUS0120 | BTL EMSCULPT | NGX | Stimulator, Muscle, Powered, For Muscle Conditioning | 2 | BTL EMSCULPT | ||
47 | B108799PO2166ENUS0110 | BTL EMSCULPT | NGX | Stimulator, Muscle, Powered, For Muscle Conditioning | 2 | BTL EMSCULPT | ||
48 | B108799PO2166ENUS0100 | BTL EMSCULPT | NGX | Stimulator, Muscle, Powered, For Muscle Conditioning | 2 | BTL EMSCULPT | ||
49 | B108785APVMUS00 | EMFEMME applicator | GEI | Electrosurgical, Cutting & Coagulation & Accessories | 2 | EMFEMME applicator | ||
50 | B108D099PO130ENUS1020 | BTL EMSELLA | KPI | Stimulator, Electrical, Non-Implantable, For Incontinence | 2 | BTL EMSELLA |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 09351609000023 | JQ-5C-B | PainPod Mi | PainPod | HI-DOW INTERNATIONAL INCORPORATED | |
2 | 08908008085352 | truSculpt Flex retractable electrode assembly | truSculpt flex comprises a system console with touchscreen LCD and sixteen elect truSculpt flex comprises a system console with touchscreen LCD and sixteen electrode handpieces, which deliver electrical impulses to the skin in direct proximity to the muscles to be stimulated. The electrical impulses are delivered in the subdermal muscular tissue area, triggering comforting and soothing muscle stimulation to achieve the intended use of strengthening, firming, and toning the muscles of the abdomen, thighs, and buttocks. | Johari Digital Healthcare Ltd. | JOHARI DIGITAL HEALTHCARE LIMITED | |
3 | 08908008085345 | truSculpt Flex | truSculpt flex comprises a system console with touchscreen LCD and sixteen elect truSculpt flex comprises a system console with touchscreen LCD and sixteen electrode handpieces, which deliver electrical impulses to the skin in direct proximity to the muscles to be stimulated. The electrical impulses are delivered in the subdermal muscular tissue area, triggering comforting and soothing muscle stimulation to achieve the intended use of strengthening, firming, and toning the muscles of the abdomen, thighs, and buttocks. | Johari Digital Healthcare Ltd. | JOHARI DIGITAL HEALTHCARE LIMITED | |
4 | 08908008085291 | Libido Machine | Physiotherapy Equipment | Unidever | JOHARI DIGITAL HEALTHCARE LIMITED | |
5 | 08908008085277 | Myorelief | Physiotherapy Equipment | 7E WELLNESS | JOHARI DIGITAL HEALTHCARE LIMITED | |
6 | 08908008085246 | ISLIM | ISLIM, EMS, 4 Channel, Multiple modes | Johari Digital Healthcare Limited | JOHARI DIGITAL HEALTHCARE LIMITED | |
7 | 08908008085093 | TORC BODY | 7E Wellness | JOHARI DIGITAL HEALTHCARE LIMITED | ||
8 | 08435393716450 | WIEMSPRO | WIEMSPRO | MEDICAL CABLES SL | ||
9 | 07640174840007 | 1.03 | Electrical Muscle Stimulator for muscle conditioning. | STIMFIT | VALMED SA | |
10 | 07640161462014 | B.BOX Classic | 420100 | BEMER Therapy Systems | BEMER INT. AG | |
11 | 07640161461086 | B.BODY Professional | 430201 | Bemer Therapy System | BEMER INT. AG | |
12 | 07640161461055 | Professional | 410201 | BEMER Therapy Systems | BEMER INT. AG | |
13 | 07640161460218 | B.SIT | 431400 | Bemer Therapy System | BEMER INT. AG | |
14 | 07630039101350 | 31500.0002 | Equipment for the extracorporeal magnetotransduction therapy. | MAGNETOLITH | STORZ MEDICAL AG | |
15 | 07290016586534 | TriLift | 30020000BK | TriLift | POLLOGEN LTD | |
16 | 06973810854245 | TU3424 | No | SHENZHEN JIAN FENG ELECTRONIC TECHNOLOGY CO., LTD. | ||
17 | 06973810853248 | TUP324 | No | SHENZHEN JIAN FENG ELECTRONIC TECHNOLOGY CO., LTD. | ||
18 | 06973810851510 | FM-B1501A | No | SHENZHEN JIAN FENG ELECTRONIC TECHNOLOGY CO., LTD. | ||
19 | 06973810850094 | FM-B2409 | No | SHENZHEN JIAN FENG ELECTRONIC TECHNOLOGY CO., LTD. | ||
20 | 06973810850070 | FM-B2407 | No | SHENZHEN JIAN FENG ELECTRONIC TECHNOLOGY CO., LTD. | ||
21 | 06973810850063 | FM-B2406 | No | SHENZHEN JIAN FENG ELECTRONIC TECHNOLOGY CO., LTD. | ||
22 | 06973810850056 | FM-B2405 | No | SHENZHEN JIAN FENG ELECTRONIC TECHNOLOGY CO., LTD. | ||
23 | 06973810850049 | FM-B2404 | No | SHENZHEN JIAN FENG ELECTRONIC TECHNOLOGY CO., LTD. | ||
24 | 06973810850032 | FM-B2403 | Belifu | SHENZHEN JIAN FENG ELECTRONIC TECHNOLOGY CO., LTD. | ||
25 | 06973810850025 | FM-B2402 | No | SHENZHEN JIAN FENG ELECTRONIC TECHNOLOGY CO., LTD. | ||
26 | 06973698299824 | VDP0016 | 644812017445 | The Gymform Abs-A-Round EMS Belt is FDA Class II 510k cleared intended to apply The Gymform Abs-A-Round EMS Belt is FDA Class II 510k cleared intended to apply electrical stimulation transcutaneously to tone, firm, and temporarily strengthen muscles through using the electric current pulse generator and the noninvasive electrodes. The EMS belt is a battery powered muscle stimulator, an over-the-counter device indicated for using to stimulate healthy muscles to facilitate and improve muscle performance in the intended areas on the body, a complimentary way to perform muscular training. | Gymform Abs-A-Round | WELL BRAIN INTERNATIONAL LIMITED |
27 | 06973698290081 | VDPGYCIND0132 | An electrical powered muscle stimulation (EMS) unit, intended to use for perform An electrical powered muscle stimulation (EMS) unit, intended to use for performing non-destructive muscular conditioning to temporarily strengthen, tone or firm muscles in a complimentary way. | Gymform Total ABS | WELL BRAIN INTERNATIONAL LIMITED | |
28 | 06973698290074 | VDPGYCIND0131 | An electrical powered muscle stimulation (EMS) unit, intended to use for perform An electrical powered muscle stimulation (EMS) unit, intended to use for performing non-destructive muscular conditioning to temporarily strengthen, tone or firm muscles in a complimentary way. | Gymform Total ABS Platinum | WELL BRAIN INTERNATIONAL LIMITED | |
29 | 06973209160087 | S3 | Wireless Electronic Pulse Stimulator for Feet | Bodi-Tek | SHENZHEN LEADING PERFECTIN TECHNOLOGY CO.,LTD | |
30 | 06973209160056 | S3 | TENS and PMSHips Pad | VONMIE | SHENZHEN LEADING PERFECTIN TECHNOLOGY CO.,LTD | |
31 | 06973209160049 | S3 | TENS and PMSFeet Pad | VONMIE | SHENZHEN LEADING PERFECTIN TECHNOLOGY CO.,LTD | |
32 | 06973209160032 | S3 | TENS and PMSAbdomen Pad | VONMIE | SHENZHEN LEADING PERFECTIN TECHNOLOGY CO.,LTD | |
33 | 06973209160025 | S3 | TENS and PMS Arms and Legs Pad | VONMIE | SHENZHEN LEADING PERFECTIN TECHNOLOGY CO.,LTD | |
34 | 06972946645703 | MC0570 | EMS Belt | NONE | ||
35 | 06972946645062 | MC0506 | EMS Belt | AB FLEX | NONE | |
36 | 06972946644850 | MC0485 | EMS Belt | AB FLEX | NONE | |
37 | 06972946644652 | MC0465 | EMS Belt | AB FLEX | NONE | |
38 | 06972946644133 | MC0413 | EMS Belt | AB FLEX | NONE | |
39 | 06972946643877 | MC0387 | EMS Belt | AB FLEX | NONE | |
40 | 06972946643860 | MC0386 | EMS Belt | AB FLEX | NONE | |
41 | 06972946642962 | MC0296 | EMS Belt | AB FLEX | NONE | |
42 | 06972929600026 | AS8012C | Adhesive electrodes are intended for use as the disposable, conductive adhesive Adhesive electrodes are intended for use as the disposable, conductive adhesive interface between the patient’s skin and the Electrical Stimulator. Adhesive Electrodes are intended to be used with marketed Electrical Stimulators, i.e. TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation). It is for OTC use. | Pohaku | SHENZHEN DAMITI TECHNOLOGY CO., LTD. | |
43 | 06972929600019 | AS8012 | Adhesive electrodes are intended for use as the disposable, conductive adhesive Adhesive electrodes are intended for use as the disposable, conductive adhesive interface between the patient’s skin and the Electrical Stimulator. Adhesive Electrodes are intended to be used with marketed Electrical Stimulators, i.e. TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation). It is for OTC use. | Pohaku | SHENZHEN DAMITI TECHNOLOGY CO., LTD. | |
44 | 06972929600002 | AS8012 | Adhesive electrodes are intended for use as the disposable, conductive adhesive Adhesive electrodes are intended for use as the disposable, conductive adhesive interface between the patient’s skin and the Electrical Stimulator. Adhesive Electrodes are intended to be used with marketed Electrical Stimulators, i.e. TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation). It is for OTC use. | Pohaku | SHENZHEN DAMITI TECHNOLOGY CO., LTD. | |
45 | 06971410780032 | LGT-232(US) | Portable Electro-Stimulation Therapy Device | GUANGZHOU LONGEST SCIENCE & TECHNOLOGY CO., LTD. | ||
46 | 06971410780025 | LGT-231(US) | Portable Electro-Stimulation Therapy Device | GUANGZHOU LONGEST SCIENCE & TECHNOLOGY CO., LTD. | ||
47 | 06971292004028 | WL-2402141 | To be used for temporary relief of pain associated with sore and aching muscles To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, arm, and leg, due to strain from exercise or normal household and work activities. | AUVON | SHENZHEN YUWEN E-COMMERCE CO., LTD. | |
48 | 06971292001225 | AS8012-045 | To be used for temporary relief of pain associated with sore and aching muscles To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, arm, and leg, due to strain from exercise or normal household and work activities. | AUVON | SHENZHEN YUWEN E-COMMERCE CO., LTD. | |
49 | 06971292001201 | AS8012-041 | Adhesive electrodes are intended for use as the disposable, conductive adhesive Adhesive electrodes are intended for use as the disposable, conductive adhesive interface between the patient’s skin and the Electrical Stimulator. Adhesive Electrodes are intended to be used with marketed Electrical Stimulators, i.e. TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation). It is for OTC use. | AUVON | SHENZHEN YUWEN E-COMMERCE CO., LTD. | |
50 | 06971292000822 | TU3424-F | TENS:The device is designed to be used for temporary relief of pain associated w TENS:The device is designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), lower extremities (leg), abdomen and bottom due to strain from exercise or normal household work activities.EMS:The device is designed to be used to stimulate healthy muscles in order to improve or facilitate muscle performance | AUVON | SHENZHEN YUWEN E-COMMERCE CO., LTD. |