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R-C1 TENS and EMS Stimulator +2 more models
FDA 510(k)Class II (US FDA 510(k))
510(k) K181688
Identifiers
- 510(k) Number
- K181688 FDA 510(k)
- FDA Product Code
- IPF FDA 510(k)
- Models / Variants
- R-C1 TENS and EMS Stimulator FDA 510(k)R-E1- EMS Stimulator FDA 510(k)R-T1 TENS Stimulator FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 890.5850 FDA 510(k)
- Regulation Number
- 890.5850 FDA 510(k)
- Advisory Committee
- Physical Medicine FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
R-C1 TENS and EMS Stimulator +2 more models by Shenzhen Roundwhale Technology Co. Ltd. — Class II — FDA_510K — listed in FDA 510(k) — 3 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 | K181688 | Class II | Active |
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Manufacturer
- Manufacturer
- Shenzhen Roundwhale Technology Co. Ltd.
- FDA Applicant
- Shenzhen Roundwhale Technology Co. , Ltd.
Sources (1)
- FDA 510(k) K181688 24 fields · synced Jun 18, 2026