TensCare Form
TensCare Form (K-FORM) is a medical device (FDA Class II) made by Tenscare Limited, cleared under FDA 510(k) K200694 on 4 Jun 2021 and listed in FDA GUDID since 28 Jun 2023 (UDI-DI 05033435136759), active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number05033435136759 | Date28 Jun 2023 | StatusListed |
| United States | FDA 510(k) | NumberK200694 | Date4 Jun 2021 | StatusActive |
Official records
- AccessGUDID record 05033435136759
- FDA 510(k) database K200694
Across registries
- FDA 510(k) K200694 decided 4 Jun 2021 Active
- FDA GUDID UDI-DI 05033435136759 listed 28 Jun 2023 Listed
Timeline
- Cleared FDA 510(k) K200694
- Listed FDA GUDID 05033435136759
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- TensCare
- Generic name
- Physical therapy transcutaneous neuromuscular electrical stimulation system
- Model / Ref / Catalog
- Form, K-FORM
- Primary DI / UDI-DI
- 05033435136759
- 510(k) Number
- FDA product code
- NUH, NGX
- GMDN term
- Physical therapy transcutaneous neuromuscular electrical stimulation system
- Device class
- Class II
- Regulation number
- 882.5890, 890.5850
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Physical therapy transcutaneous neuromuscular electrical stimulation system.