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Ergo Lite
EUDAMEDFDA UDIClass I (EU MDR)
Ref 110404000035Model ERG LITE (KM-2501)
Identity
- Trade Name
- Ergo Lite EUDAMEDKarma FDA UDI
- Generic Name
- Push-rim manual wheelchair, non-bariatric FDA UDI
- Device Name
- Ergo Lite EUDAMED
- Model / Reference
- ERG LITE (KM-2501) EUDAMED110404000035 EUDAMEDKM-2501 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04719873857258 EUDAMEDFDA UDI
- Basic UDI-DI
- 471987385ErgoXT 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
Ergo Lite 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 | 471987385ErgoXT | 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 82fced4c-569f-461e-912d-953d2d1f6dba 61 fields · synced Oct 9, 2026
- FDA UDI 2e9bc0a1-2dc1-4039-9127-8912346e6ce5 34 fields · synced May 30, 2026