Identity
- Trade Name
- KM-8000 EUDAMEDKarma FDA UDI
- Generic Name
- Push-rim manual wheelchair, non-bariatric FDA UDI
- Device Name
- KM-8000 EUDAMED
- Model / Reference
- KM-8000Ⅲ EUDAMED110404000004 EUDAMEDKM-8020IIIX, KM-8520IIIX, KM-8020IIIXHB FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04719873857067 EUDAMEDFDA UDI
- Basic UDI-DI
- 471987385KM-8000GM EUDAMED
- Direct Marketing DI
- 04719873857067 EUDAMED
- 510(k) Number
- K062309 FDA UDI
- FDA Product Code
- IOR FDA UDI
- EMDN Code
- Y122103,Y122106 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
- Spain 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
Km-8000 by Karma 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 | 471987385KM-8000GM | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Karma Medical Products Co., Ltd
- EUDAMED SRN
- TW-MF-000013206
- Authorised Representative
- KARMA MOBILITY S.L. ES-AR-000004852
Sources (2)
- EUDAMED 1fad4a8b-0434-40ab-9dcd-b233ee6b9b0d 61 fields · synced Oct 9, 2026
- FDA UDI eabe303b-c6d6-47b5-a1cc-46bd1295ef65 34 fields · synced May 30, 2026