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TuffCare 397XDB

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 Number04719876192318 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  • Withdrawn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
Push-rim manual wheelchair, bariatric
Model / Reference
397XDB
Primary DI / UDI-DI
04719876192318
FDA Product Code
IOR
GMDN Term
Push-rim manual wheelchair, bariatric
Device Class
Class I
Regulation Number
890.3850
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

  • Serial Number
  • 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
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No