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Buttock Muscle Stimulator Model Wl-2413b +1 more model
FDA 510(k)Class II (US FDA 510(k))
510(k) K123075
Identifiers
- 510(k) Number
- K123075 FDA 510(k)
- FDA Product Code
- NGX FDA 510(k)
- Models / Variants
- Buttock Muscle Stimulator Model Wl-2413b FDA 510(k)Buttock Muscle Stimulator Mode Wl-2413e 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)
Buttock Muscle Stimulator Model Wl-2413b +1 more model by Well-Life Healthcare Limited — Class II — FDA_510K — listed in FDA 510(k) — 2 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 | K123075 | Class II | Active |
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Manufacturer
- Manufacturer
- Well-Life Healthcare Limited
Sources (1)
- FDA 510(k) K123075 24 fields · synced Jun 18, 2026