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Electronic Stimulator - uNeck-9515A
FDA 510(k)Class II (US FDA 510(k))
510(k) K223428
Identifiers
- 510(k) Number
- K223428 FDA 510(k)
- FDA Product Code
- NUH FDA 510(k)
- Models / Variants
- Models: uLumb-9530A FDA 510(k)uLumb-9531A FDA 510(k)uLumb-9532A FDA 510(k)uLumb-9533A FDA 510(k)LQ-9525B FDA 510(k)uNeck-9512A FDA 510(k)uNeck-9515A FDA 510(k)uNeck-9517B FDA 510(k)uNeck-9518A FDA 510(k)uNeck-9519A FDA 510(k)uNeck-9521A FDA 510(k)uNeck-9529A FDA 510(k)LQ-9535A 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)
Electronic Stimulator - uNeck-9515A by Shenzhen Leqing Medical Instrument Co., Ltd. — Class II — FDA_510K — listed in FDA 510(k) — 13 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 | K223428 | Class II | Active |
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Manufacturer
- Manufacturer
- Shenzhen Leqing Medical Instrument Co., Ltd.
Sources (1)
- FDA 510(k) K223428 24 fields · synced Jun 19, 2026