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Electrically powered wheelchair
EUDAMEDFDA UDIFDA 510(k)Class I (EU MDR)
Ref HP202(Jazzy Carbon 27X)Model HP358E、HP358EA、HP202、HP201、HP200、HP458E、EY07、EY18、P15、P55、HP203、HP204、HP205、HP206、HP207、HP208、HP209、HP210、HP211、HP212510(k) K241337
Identity
- Trade Name
- Hi-Fortune FDA UDI
- Generic Name
- Electric-motor-driven wheelchair, occupant-controlled FDA UDI
- Device Name
- Electrically powered wheelchair EUDAMED
- Model / Reference
- HP358E、HP358EA、HP202、HP201、HP200、HP458E、EY07、EY18、P15、P55、HP203、HP204、HP205、HP206、HP207、HP208、HP209、HP210、HP211、HP212 EUDAMEDHP202(Jazzy Carbon 27X) EUDAMEDHP202 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06973852593331 EUDAMEDFDA UDI
- Basic UDI-DI
- 697385259Ewheelchair95 EUDAMED
- 510(k) Number
- K241337 FDA UDI
- FDA Product Code
- ITI FDA UDI
- EMDN Code
- Y122127 ELECTRIC WHEELCHAIRS EUDAMED
- GMDN Term
- Electric-motor-driven wheelchair, occupant-controlled FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 890.3860 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
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
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
Electrically powered wheelchair by Kunshan Hi-Fortune Health Products Co., Ltd — Class I — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K241337 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 697385259Ewheelchair95 | Class I | Active |
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Manufacturer
- Manufacturer
- Kunshan Hi-Fortune Health Products Co., Ltd
- EUDAMED SRN
- CN-MF-000035403
- FDA Applicant
- Kunshan Hi-Fortune Health Products Co., Ltd.
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (3)
- EUDAMED e9d78515-61ea-4ddf-93f2-a9e0dcc63cfa 85 fields · synced Jun 18, 2026
- FDA UDI 1485d2fc-7df7-4640-a8ca-226df9d0b756 33 fields · synced May 27, 2026
- FDA 510(k) K241337 1 fields · synced May 18, 2026