← Back to catalogue

e-fix®

FDA UDI

Class II (US FDA UDI)

by Alber GmbH

Identity

Trade Name
e-fix® FDA UDI
Generic Name
Wheelchair electric-motor-driven propulsion system FDA UDI
Model / Reference
E35 eco FDA UDI

Identifiers

Primary DI / UDI-DI
04046727216894 FDA UDI
510(k) Number
K161241 FDA UDI
FDA Product Code
ITI FDA UDI
GMDN Term
Wheelchair electric-motor-driven propulsion system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
890.3860 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

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

Category: Wheelchair electric-motor-driven propulsion system

e-fix is a wheelchair electric-motor-driven propulsion system designed for individuals with mobility impairments. It features a robust and reliable motor unit, precision-made components, and advanced control systems to provide efficient and comfortable transportation.

Similar devices

Also classified as Wheelchair electric-motor-driven propulsion system.

Cleared under the same submission

K161241 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Alber GmbH

Sources (1)

  • FDA UDI b2e71508-f749-4850-9110-b5a2b1f5eaae 33 fields · synced Jul 26, 2026