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GaitKeeper All GaitKeeper devices

by Mobility Research, Inc

Ref GaitKeeper

GaitKeeper All GaitKeeper devices is a standard treadmill (EU MDR Class I; FDA Class I; FDA product code IOL, Treadmill, Powered) made by Mobility Research, Inc, registered in EUDAMED on 4 Aug 2026 (Basic UDI-DI 08500040235GKR2) and listed in FDA GUDID since 14 Jul 2023 (UDI-DI 00850040235005), active as of 25 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08500040235GKR2 Basic UDI-DI 00850040235005UDI-DIDate4 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00850040235005 UDI-DI Date14 Jul 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08500040235GKR2 registered 4 Aug 2026 Active
  • FDA GUDID UDI-DI 00850040235005 listed 14 Jul 2023 Listed

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Timeline

2 dated events

  1. Listed FDA GUDID 00850040235005
  2. Registered EUDAMED 08500040235GKR2

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
GaitKeeper
Generic name
Standard treadmill, powered
Model / reference
GaitKeeper EUDAMED
All GaitKeeper devices GUDID
Primary DI / UDI-DI
00850040235005
Basic UDI-DI
08500040235GKR2
FDA product code
IOL
EMDN code
Y0504 Arms, torso and legs re-education devices
GMDN term
Standard treadmill, powered
Device class
Class I
Regulation number
890.5380
EU registration type
Standard device
EU market of registration
Denmark
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / referenceEUDAMED
GaitKeeper
GUDID
All GaitKeeper devices

Related devices

Category: Standard treadmill, powered

Similar devices in this category

Other devices filed under ABILITIES LEARNING AND TRAINING DEVICES.

Other devices from Mobility Research, Inc

Properties

  • Single use
  • Premarket exempt
  • Serial number
Other properties (22, all answered No)