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FDM-SX System 01543005

by zebris MEDICAL GmbH

FDM-SX System 01543005 is a Class I device made by zebris MEDICAL GmbH, listed in FDA GUDID since 11 Aug 2023 (UDI-DI B915015430051), 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 NumberB915015430051 UDI-DI Date11 Aug 2023ListedStatusListed 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  • Withdrawn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
FDM-SX System
Generic name
Gait analysis system
Model / Ref / Catalog
01543005
Primary DI / UDI-DI
B915015430051
FDA product code
KHX
GMDN term
Gait analysis system
Device class
Class I
Regulation number
890.1575
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code KHX (Platform, Force-Measuring).

Other devices from zebris MEDICAL GmbH

See all devices from zebris MEDICAL GmbH →

Properties

  • Prescription use
  • Premarket exempt
  • Serial number
  • Manufacturing date
Other properties (11, all answered No)