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Sunmas TENS & PMS (Model SM9187 +2 more)
FDA 510(k)Class II (US FDA 510(k))
510(k) K190009
Identifiers
- 510(k) Number
- K190009 FDA 510(k)
- FDA Product Code
- NUH FDA 510(k)
- Models / Variants
- Model SM9187 FDA 510(k)SM9180L FDA 510(k)SM9180S 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)
Sunmas TENS & PMS (Model SM9187 +2 more) by Hong Qiangxing (Shenzhen) Electronics Limited — 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 | K190009 | Class II | Active |
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Manufacturer
- Manufacturer
- Hong Qiangxing (Shenzhen) Electronics Limited
Sources (1)
- FDA 510(k) K190009 24 fields · synced Jun 18, 2026