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Manual Wheelchair, Model A011
FDA 510(k)EUDAMEDClass I (US FDA 510(k))
510(k) K201461
Identifiers
- 510(k) Number
- K201461 FDA 510(k)
- FDA Product Code
- IOR FDA 510(k)
Classification
- Device Class
- Class I FDA 510(k)
- Legislation / Framework
- 21 CFR Part 890.3850 FDA 510(k)
- Regulation Number
- 890.3850 FDA 510(k)
- Advisory Committee
- Physical Medicine FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Manual Wheelchair, Model A011 by Ningbo Shenyu Medical Equipment Co., Ltd — Class I — MDR, FDA_510K — listed in FDA 510(k), EUDAMED
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
MDR
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Active |
| FDA 510(k) | United States | FDA_510K | K201461 | Class I | Active |
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Manufacturer
- Manufacturer
- Ningbo Shenyu Medical Equipment Co., Ltd
- FDA Applicant
- Ningbo Shenyu Medical Equipment Co.,Ltd
Sources (2)
- FDA 510(k) K201461 24 fields · synced Oct 7, 2026
- EUDAMED 1 fields · synced May 19, 2026