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Neurolutions Ipsihand Upper Extremity Rehabilitation System FGS-1000-01

by Neurolutions, Inc

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00850005539018 UDI-DI Date12 Sep 2022ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Neurolutions Ipsihand Upper Extremity Rehabilitation System
Generic Name
Neuro-controlled joint movement exoskeleton
Model / Reference
FGS-1000-01
Primary DI / UDI-DI
00850005539018
De Novo Number
FDA Product Code
QOL
GMDN Term
Neuro-controlled joint movement exoskeleton
Device Class
Class II
Regulation Number
890.5420
GUDID distribution status
In Commercial Distribution

Related devices

Category: Neuro-controlled joint movement exoskeleton

Cleared under the same submission (DEN200046)

Other devices from Neurolutions, Inc

Properties

  • Prescription Use
  • Serial Number
  • Manufacturing Date

Other properties (11)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No