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TuffCare W500BW

by Shin-I Medical Manufacturing Co., Ltd.

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

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 Number04719876190253 UDI-DI Date8 Jul 2026ListedStatusListed 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  • Withdrawn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
TuffCare
Generic Name
Basic walking frame, foldable
Model / Reference
W500BW
Primary DI / UDI-DI
04719876190253
FDA Product Code
ITJ
GMDN Term
Basic walking frame, foldable
Device Class
Class I
Regulation Number
890.3825
GUDID distribution status
In Commercial Distribution

Other devices from Shin-I Medical Manufacturing Co., Ltd.

See all devices from Shin-I Medical Manufacturing Co., Ltd. →

Properties

  • Premarket Exempt
  • Lot / Batch Number
  • Manufacturing Date

Other properties (11)

  • 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
  • Serial Number: No
  • Expiration Date: No