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Back Brace JP03A01

by Gcmedica Enterprise Ltd.(Wuxi)

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number06974500613432 UDI-DI Date8 Dec 2025ListedStatusListed 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  • Withdrawn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
Back Brace
Generic Name
Lumbar spine orthosis
Model / Reference
JP03A01
Description
Adjustable Fiber Contents: Black mesh:100% polyester Black elastic band: 87.9% polyester 12.1% Spandex
Primary DI / UDI-DI
06974500613432
FDA Product Code
IPY
GMDN Term
Lumbar spine orthosis
Device Class
Class I
Regulation Number
890.3490
GUDID distribution status
In Commercial Distribution

Other devices from Gcmedica Enterprise Ltd.(Wuxi)

See all devices from Gcmedica Enterprise Ltd.(Wuxi) →

Properties

  • Over-the-Counter
  • Premarket Exempt

Other properties (12)

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