Identity
- Trade Name
- Valmax FDA UDI
- Generic Name
- Manual traction wheelchair FDA UDI
- Model / Reference
- DME.003 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06974231101277 FDA UDI
- 510(k) Number
- K112816 FDA UDI
- FDA Product Code
- IOR FDA UDI
- GMDN Term
- Manual traction wheelchair FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.3850 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Valmax by Supply Line Medical — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K112816 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Supply Line Medical
Sources (1)
- FDA UDI 4fca4850-9c09-40c5-85dc-1c3c307e1bb7 34 fields · synced May 30, 2026