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e-motion

EUDAMEDFDA 510(k)FDA UDI

Class I (EU MDR)

Ref 1592520Model e-motion M25510(k) K003449Ref 1592698Ref 1592697Ref 1592559

by Alber GmbH

Identity

Trade Name
e-motion EUDAMED
e-motion® FDA UDI
Generic Name
Wheelchair electric-motor-driven propulsion system FDA UDI
Device Name
e-motion M25 EUDAMED
Model / Reference
e-motion M25 EUDAMED
1592520 EUDAMED
1592698 EUDAMED
1592697 EUDAMED
1592559 EUDAMED
M25 FDA UDI

Identifiers

Primary DI / UDI-DI
04046727184476 EUDAMED
04046727184865 EUDAMEDFDA UDI
04046727186258 EUDAMEDFDA UDI
04046727186241 EUDAMEDFDA UDI
Basic UDI-DI
4046727e-motionM258K EUDAMED
510(k) Number
K003449 FDA 510(k)
K192618 FDA UDI
FDA Product Code
ITI FDA 510(k)FDA UDI
EMDN Code
Y122410 ELECTRIC PROPULSION UNIT EUDAMED
GMDN Term
Wheelchair electric-motor-driven propulsion system FDA UDI

Classification

Device Class
Class I EUDAMED
Class II FDA 510(k)FDA UDI
Legislation / Framework
21 CFR Part 890.3860 FDA 510(k)
Regulation Number
890.3860 FDA 510(k)FDA UDI
Market of Registration
Germany EUDAMED
Advisory Committee
Physical Medicine FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)
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 510(k), FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

European Union Active

CE/MDR

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Manufacturer

Manufacturer
Alber GmbH
EUDAMED SRN
DE-MF-000005502

Sources (8)

  • EUDAMED 7f7f0e40-a7bc-450e-8d81-76e453ad1539 61 fields · synced Jul 28, 2026
  • FDA 510(k) K003449 24 fields · synced May 18, 2026
  • FDA UDI 2ddf504d-3171-4945-9dc0-78c888e050b1 33 fields · synced May 27, 2026
  • FDA UDI 92389f72-0a61-4f1d-bc1a-35ce813f8a13 33 fields · synced May 30, 2026
  • FDA UDI 0189cdd6-5233-4c27-87a8-b20402e79a96 33 fields · synced May 30, 2026
  • EUDAMED d42dca3e-2a1f-467c-8123-45c745c3843e 61 fields · synced Jul 14, 2026
  • EUDAMED 21426da8-327f-44a9-b963-82047b340db6 61 fields · synced Jul 23, 2026
  • EUDAMED 78a378a1-6bc8-4b0d-87d0-546d1a411b2c 61 fields · synced Jul 28, 2026