Electrically powered wheelchair
EUDAMEDFDA UDIFDA 510(k)Class I (EU MDR)
Identity
- Trade Name
- Hi-Fortune FDA UDI
- Generic Name
- Multi-terrain sports wheelchair, electric-motor-driven FDA UDI
- Device Name
- Electrically powered wheelchair EUDAMEDThe device is a motor-driven, and indoor transportation vehicle with the intended use to provide mobility to a disabled or an elderly person limited to a seated position. FDA UDI
- Model / Reference
- HP358E、HP358EA、HP202、HP201、HP200、HP458E、EY07、EY18、P15、P55、HP203、HP204、HP205、HP206、HP207、HP208、HP209、HP210、HP211、HP212 EUDAMEDNA EUDAMEDP16H FDA UDI
- Description
- The device is a motor-driven, and indoor transportation vehicle with the intended use to provide mobility to a disabled or an elderly person limited to a seated position. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06973852594581 EUDAMEDFDA UDI
- Basic UDI-DI
- 697385259Ewheelchair95 EUDAMED
- 510(k) Number
- K212503 FDA UDI
- FDA Product Code
- ITI FDA UDI
- EMDN Code
- Y122127 ELECTRIC WHEELCHAIRS EUDAMED
- GMDN Term
- Multi-terrain sports wheelchair, electric-motor-driven 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
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
Yes
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
These devices are electrically powered wheelchairs classified under nomenclature code Y122127, designed for mobility assistance. They provide motorized propulsion for individuals with limited mobility, enabling independent movement in various environments. The wheelchairs are active medical devices, incorporating electrical components for operation.
The wheelchairs are non-sterile, non-reusable, and non-implantable, supplied as single-use or for direct patient use. They are not intended for reprocessing or reuse. The devices comply with FDA 510(k) clearance and MDR regulations, with models including HP358E, HP358EA, HP202, HP201, HP200, HP458E, EY07, EY18, P15, P55, HP203, HP204, HP205, HP206, HP207, HP208, HP209, HP210, HP211, and HP212. Each model is assigned a unique UDI for traceability.
Frequently asked questions
What is the purpose of these electrically powered wheelchairs?
These devices are designed for mobility assistance, providing motorized propulsion for individuals with limited mobility to enable independent movement in various environments.
Are these wheelchairs reusable or sterile?
The wheelchairs are non-sterile and non-reusable, supplied as single-use or for direct patient use. They are not intended for reprocessing or reuse.
What models of electrically powered wheelchairs are available?
Available models include HP358E, HP358EA, HP202, HP201, HP200, HP458E, EY07, EY18, P15, P55, HP203, HP204, HP205, HP206, HP207, HP208, HP209, HP210, HP211, and HP212.
What regulatory approvals do these wheelchairs have?
The wheelchairs comply with FDA 510(k) clearance and MDR regulations, with each model assigned a unique UDI for traceability.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Kunshan Hi-Fortune Health Products Co.,ltd., Hi-Fortune Health Products Co., Ltd, Electric power wheelchair - Kunshan Hi-Fortune Health Products Co.,ltd., Kunshan Hi-Fortune Health Products Co., Ltd., HP358EA Electrically Powered Wheelchair
Authorization Coverage (2 countries)
Regulatory Authorizations
FDA_510K
FDA_510K
FDA_510K
FDA_510K
FDA_510K
FDA_510K
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K244003 | Class I | Active |
| FDA 510(k) | United States | FDA_510K | K211647 | Class I | Active |
| FDA 510(k) | United States | FDA_510K | K212503 | Class I | Active |
| FDA 510(k) | United States | FDA_510K | K241632 | Class I | Active |
| FDA 510(k) | United States | FDA_510K | K243961 | Class I | Active |
| FDA 510(k) | United States | FDA_510K | K243962 | 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 5c1fc55c-e2ef-466c-85fe-6a11747e5e28 85 fields · synced Oct 6, 2026
- FDA UDI 95127a76-f33a-4c3c-8935-da531375ba33 34 fields · synced May 30, 2026
- FDA 510(k) K244003 1 fields · synced May 18, 2026