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SMARTSTEP Gait Analysis 1.0

by Blatchford, Inc. GUDID

Listed FDA GUDID listing, no authorization on record

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number05050649231230 UDI-DIDate14 Jul 2026ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Recalls

0 recalls · FDA

No FDA recalls on record, checked 23 Oct 2026.

Specification

GUDID

Trade Name
SMARTSTEP Gait Analysis
Generic Name
Biomechanical function analysis/rehabilitation software
Model / Reference
1.0
Primary DI / UDI-DI
05050649231230
FDA Product Code
ISD
GMDN Term
Biomechanical function analysis/rehabilitation software
Device Class
Class II
Regulation Number
890.5360
GUDID distribution status
In Commercial Distribution

Properties

  • Premarket Exempt
  • Manufacturing Date

Other properties (12)

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