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e-motion
EUDAMEDFDA UDIFDA 510(k)Class I (EU MDR)
Ref 1592662Model e-motion M25
by Alber GmbH
Identity
- Trade Name
- e-motion EUDAMEDe-motion® FDA UDI
- Generic Name
- Wheelchair electric-motor-driven propulsion system FDA UDI
- Device Name
- e-motion M25 EUDAMED
- Model / Reference
- e-motion M25 EUDAMED1592662 EUDAMEDM25 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04046727185893 EUDAMEDFDA UDI
- Basic UDI-DI
- 4046727e-motionM258K EUDAMED
- 510(k) Number
- K192618 FDA UDI
- FDA Product Code
- ITI FDA UDI
- EMDN Code
- Y122410 ELECTRIC PROPULSION UNIT EUDAMED
- GMDN Term
- Wheelchair electric-motor-driven propulsion system 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
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
Yes
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
e-motion by Alber GmbH — Class I — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
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 | K192618 | Class I | Active |
| FDA 510(k) | United States | FDA_510K | K221215 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 4046727e-motionM258K | Class I | Active |
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Manufacturer
- Manufacturer
- Alber GmbH
- EUDAMED SRN
- DE-MF-000005502
Sources (3)
- EUDAMED 5d3a477c-9812-421c-82bc-d36989dbb21a 61 fields · synced Jul 22, 2026
- FDA UDI 6c0e8a08-257e-48d7-a630-847c7926f0a3 33 fields · synced May 29, 2026
- FDA 510(k) K192618 1 fields · synced May 18, 2026