Identity
- Trade Name
- TensCare FDA UDI
- Generic Name
- Physical therapy transcutaneous neuromuscular electrical stimulation system FDA UDI
- Device Name
- Form is a variant of the Perfect EMS medical device. It has one programme identical to one programme on the Perfect EMS. Form is an innovative electrical muscle stimulator used to target muscles for local and wholebody muscle recovery. The stimulator delivers small electrical impulses via smart, body-worn electrodes, designed to optimise muscle coverage, motor point activation and elicit small muscle contractions. This type of ‘active recovery’ helps the muscle recovery process without causing cardiovascular fatigue. Enhance your recovery routine and return to activity faster with Form. FDA UDI
- Model / Reference
- Form FDA UDI
- Description
- Form is a variant of the Perfect EMS medical device. It has one programme identical to one programme on the Perfect EMS. Form is an innovative electrical muscle stimulator used to target muscles for local and wholebody muscle recovery. The stimulator delivers small electrical impulses via smart, body-worn electrodes, designed to optimise muscle coverage, motor point activation and elicit small muscle contractions. This type of ‘active recovery’ helps the muscle recovery process without causing cardiovascular fatigue. Enhance your recovery routine and return to activity faster with Form. FDA UDI
Identifiers
- Catalog Number
- K-FORM FDA UDI
- Primary DI / UDI-DI
- 05033435136759 FDA UDI
- 510(k) Number
- K200694 FDA UDI
- FDA Product Code
- NUH FDA UDINGX FDA UDI
- GMDN Term
- Physical therapy transcutaneous neuromuscular electrical stimulation system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.5890 FDA UDI890.5850 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Physical therapy transcutaneous neuromuscular electrical stimulation system
TensCare by Tenscare Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K200694 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Tenscare Limited
Sources (1)
- FDA UDI 68e073d2-ed30-415f-9763-809b7527e905 35 fields · synced May 30, 2026