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Ultium 881

by Noraxon USA, Inc.

Ultium 881 is a Class II device made by Noraxon USA, Inc., listed in FDA GUDID since 21 Nov 2019 (UDI-DI 00816271020278), registry data as of 22 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00816271020278 UDI-DI Date21 Nov 2019ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
Ultium
Generic name
Kinesiology/electromyographic sensor set
Model / reference
881
Primary DI / UDI-DI
00816271020278
FDA product code
HCC
GMDN term
Kinesiology/electromyographic sensor set
Device class
Class II
Regulation number
882.5050
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code HCC (Device, Biofeedback).

Other devices from Noraxon USA, Inc.

See all devices from Noraxon USA, Inc. →

Properties

  • Premarket exempt
  • Serial number
Other properties (13, all answered No)