← Back to catalogue
Electrical Stimulator - (R-C1 TENS +3 more)
FDA 510(k)Class II (US FDA 510(k))
510(k) K180956
Identifiers
- 510(k) Number
- K180956 FDA 510(k)
- FDA Product Code
- NUH FDA 510(k)
- Models / Variants
- R-C1 TENS FDA 510(k)EMS stimulator FDA 510(k)Model R-E1 EMS stimulator FDA 510(k)Model R-T1 TENS Stimulator 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)
Electrical Stimulator - (R-C1 TENS +3 more) by Shenzhen Roundwhale Technology Co. Ltd. — Class II — FDA_510K — listed in FDA 510(k) — 4 models
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 | K180956 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Shenzhen Roundwhale Technology Co. Ltd.
- FDA Applicant
- Shenzhen Roundwhale Technology Co. , Ltd.
Sources (1)
- FDA 510(k) K180956 24 fields · synced Jun 18, 2026