Identity
- Trade Name
- Heartway Medical Products Co., Ltd FDA UDI
- Generic Name
- Assistive scooter, electric-motor-driven FDA UDI
- Device Name
- Power scooter EUDAMED
- Model / Reference
- S8 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 04719871230442 EUDAMEDFDA UDI
- Basic UDI-DI
- 471987123PSYV EUDAMED
- Direct Marketing DI
- 04719871230442 EUDAMED
- 510(k) Number
- K092155 FDA UDI
- FDA Product Code
- INI FDA UDI
- EMDN Code
- Y122124 ELECTRIC SCOOTERS EUDAMED
- GMDN Term
- Assistive scooter, electric-motor-driven FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 890.3800 FDA UDI
- Market of Registration
- Northern Ireland 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
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
Power scooter by Heartway Medical Products Co., Ltd. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | 471987123PSYV | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Heartway Medical Products Co. Ltd
- EUDAMED SRN
- TW-MF-000003315
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (2)
- EUDAMED a95f8bb0-cfff-4d51-bddc-c39eabccbee3 61 fields · synced Oct 6, 2026
- FDA UDI 7fb6f096-23ef-4b0e-8dfe-8c1e7a881f2d 33 fields · synced May 30, 2026