← Back to catalogue
Transcutaneous Electrical Nerve Stimulator, Model: KTR-4031, KTR-4032, KTR-4012…
FDA 510(k)Class II (US FDA 510(k))
510(k) K222870
Identifiers
- 510(k) Number
- K222870 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)
Transcutaneous Electrical Nerve Stimulator, Model: KTR-4031, KTR-4032, KTR-4012… by Shenzhen Kentro Medical Electronics Co., Ltd — Class II — FDA_510K…
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K222870 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Shenzhen Kentro Medical Electronics Co., Ltd
- FDA Applicant
- Shenzhen Kentro Medical Electronics Co., Ltd.
Sources (1)
- FDA 510(k) K222870 24 fields · synced Jun 18, 2026