Identity
- Trade Name
- FREINS/ BRAKES (PAIR) FDA UDI
- Generic Name
- Wheelchair brakes FDA UDI
- Model / Reference
- 0006-00-01 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03664560000114 FDA UDI
- 510(k) Number
- K051709 FDA UDI
- FDA Product Code
- IQC FDA UDI
- GMDN Term
- Wheelchair brakes FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.3880 FDA UDI
- Commercial Distribution
- 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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Wheelchair brakes
Freins/ Brakes (pair) by Sarl Vipamat — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Wheelchair brakes.
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- MEDLINE — MEDLINE INDUSTRIES, INC. · Class I
Cleared under the same submission
K051709 also covers:
- ACCOUDOIRS ESCAMOTABLE REGLABLE ET ORIENTABLE BLEU MARBRE/ ARMRESTS BLUE MARBLED — SARL VIPAMAT
- ACCOUDOIRS ESCAMOTABLE REGLABLE ET ORIENTABLE ROSE/ ARMRESTS PINK — SARL VIPAMAT
- APPUI-TETE REGLABLE AMOVIBLE/ ADJUSTABLE HEADREST — SARL VIPAMAT
- APPUI-TETE REGLABLE AMOVIBLE/ ADJUSTABLE HEADREST — SARL VIPAMAT
- DOSSIER FIXE EN HAUTEUR ET INCLINABLE/ FIXED SEAT BACK FRAME — SARL VIPAMAT
- DOSSIER REGLABLE EN HAUTEUR INCLINABLE/ ADJUSTABLE SEAT BACK FRAME — SARL VIPAMAT
- FAUTEUIL HIPPOCAMPE L BLEU MARBRE/ WHEELCHAIR HIPPOCAMPE L BLUE MARBLED — SARL VIPAMAT
- FAUTEUIL HIPPOCAMPE L ROSE/ WHEELCHAIR HIPPOCAMPE L PINK — SARL VIPAMAT
- FAUTEUIL HIPPOCAMPE M BLEU MARBRE/ WHEELCHAIR HIPPOCAMPE M BLUE MARBLED — SARL VIPAMAT
- FAUTEUIL HIPPOCAMPE M ROSE/ WHEELCHAIR HIPPOCAMPE M PINK — SARL VIPAMAT
- FAUTEUIL HIPPOCAMPE PISCINE/ WHEELCHAIR SWIMMING POOL HIPPOCAMPE — SARL VIPAMAT
- FAUTEUIL HIPPOCAMPE S BLEU MARBRE/ WHEELCHAIR HIPPOCAMPE S BLUE MARBLED — SARL VIPAMAT
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 II | Pending data |
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Manufacturer
- Manufacturer
- Sarl Vipamat
Sources (1)
- FDA UDI fc3a8537-25ea-4db6-99b9-060611333200 33 fields · synced May 30, 2026