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Nexus Wheelchair Cushion/Formerly Biothotic
FDA 510(k)Class I (US FDA 510(k))
510(k) K923186
by Roho, Inc.
Identifiers
- 510(k) Number
- K923186 FDA 510(k)
- FDA Product Code
- KNN FDA 510(k)
Classification
- Device Class
- Class I FDA 510(k)
- Legislation / Framework
- 21 CFR Part 890.3920 FDA 510(k)
- Regulation Number
- 890.3920 FDA 510(k)
- Advisory Committee
- Physical Medicine FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Nexus Wheelchair Cushion/Formerly Biothotic by Roho, Inc. — Class I — FDA_510K — listed in FDA 510(k) — regulatory data on deviCERTS
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 | K923186 | Class I | Active |
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Manufacturer
- Manufacturer
- Roho, Inc.
Sources (1)
- FDA 510(k) K923186 24 fields · synced Jun 19, 2026