Skip to content

emPOWER em4

by Bionx Medical Technologies, Inc.

emPOWER em4 is a Class II device made by Bionx Medical Technologies, Inc., listed in FDA GUDID since 27 Oct 2016 (UDI-DI B155EM40), registry data as of 23 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberB155EM40 UDI-DI Date27 Oct 2016ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name
emPOWER
Generic name
Portable computer
Model / reference
em4
Primary DI / UDI-DI
B155EM40
FDA product code
ISW
GMDN term
Portable computer
Device class
Class II
Regulation number
890.3500
GUDID distribution status
In Commercial Distribution

Related devices

Category: Portable computer

Similar devices

Other devices filed under FDA product code ISW (Assembly, Knee/Shank/Ankle/Foot, External).

Other devices from Bionx Medical Technologies, Inc.

See all devices from Bionx Medical Technologies, Inc. →

Properties

  • Prescription use
  • Premarket exempt
  • Serial number
Other properties (12, all answered No)