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Fs Series Manual Wheelchair
EUDAMEDFDA UDIClass I (EU MDR)
Ref FS909P-46 Model FS875-46,FS800LBJPF5,FS951B-56,FS879LAJ-46,FS205LHQ-46,FS980LA-41,FS258LBGPY,FS958LBCGPY-38,FS958LBCGPY-44,FS903LPQF11-46,FS909P-46,FS903LAJPQF9-46,FS863AJPF1-46,FS809P-46,FS805LABJ-46,FS874LPF5-46,FS800LBJF2,FS800LBF3,FS902C-46FS908LABJPF29FS908LABJPF30
Identity
- Trade Name
- FS-Series Wheelchair FDA UDI
- Generic Name
- Push-rim manual wheelchair, non-bariatric FDA UDI
- Device Name
- FS SERIES MANUAL WHEELCHAIR EUDAMEDMECHANICAL WHEELCHAIR FDA UDI
- Model / Reference
- FS875-46,FS800LBJPF5,FS951B-56,FS879LAJ-46,FS205LHQ-46,FS980LA-41,FS258LBGPY,FS958LBCGPY-38,FS958LBCGPY-44,FS903LPQF11-46,FS909P-46,FS903LAJPQF9-46,FS863AJPF1-46,FS809P-46,FS805LABJ-46,FS874LPF5-46,FS800LBJF2,FS800LBF3,FS902C-46FS908LABJPF29FS908LABJPF30 EUDAMEDFS909P-46 EUDAMEDFS909 FDA UDI
- Description
- MECHANICAL WHEELCHAIR FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06938001010664 EUDAMEDFDA UDI
- Basic UDI-DI
- 69380010005QR EUDAMED
- 510(k) Number
- K041814 FDA UDI
- FDA Product Code
- IOR FDA UDI
- EMDN Code
- Y122106 REAR SELF-PROPELLED WHEELCHAIRS EUDAMED
- GMDN Term
- Push-rim manual wheelchair, non-bariatric FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.3850 FDA UDI
- Market of Registration
- Türkiye EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Fs Series Manual Wheelchair by Foshan Dongfang Medical Equipment Manufactory (ltd.) — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69380010005QR | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Foshan Dongfang Medical Equipment Manufactory Ltd.
- EUDAMED SRN
- CN-MF-000036028
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (2)
- EUDAMED e0bbaad4-c380-43d2-b3d4-af055eba11a0 61 fields · synced Jun 18, 2026
- FDA UDI 4cbfb120-88d4-4b37-a386-3ae539507b7d 34 fields · synced May 30, 2026