Unicare (K-UNICARE-USA)
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
by TensCare Ltd
Identifiers
- 510(k) Number
- K231053 FDA 510(k)
- FDA Product Code
- NUH FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 882.5890 FDA 510(k)
- Regulation Number
- 882.5890 FDA 510(k)
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Unicare (K-UNICARE-USA) is a transcutaneous electrical nerve stimulation (TENS) device, designed to provide pain relief through low-voltage electrical currents applied to the skin. It is classified under the product code NUH and falls under the regulatory category of substantially equivalent devices, as determined by the FDA’s Neurology Advisory Committee.
This device is intended for single-use or reusable application, depending on manufacturer guidelines, and is supplied as a portable unit for home or clinical use. It operates under FDA 510(k) clearance and MDR compliance, with no third-party involvement in its regulatory submission. Storage and handling follow standard electrical medical device protocols, ensuring proper functionality and safety for intended use.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K231053 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- TensCare Ltd
- FDA Applicant
- Tenscare, Ltd.
Sources (2)
- FDA 510(k) K231053 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 18, 2026