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Youwen black shoulder

by Shanghai Youwen Medical Technology 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 Number06975803350208 UDI-DI Date25 Sep 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  • Withdrawn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
Youwen
Generic Name
Physical therapy transcutaneous neuromuscular electrical stimulation system
Model / Reference
black shoulder
Primary DI / UDI-DI
06975803350208
FDA Product Code
ILO
GMDN Term
Physical therapy transcutaneous neuromuscular electrical stimulation system
Device Class
Class II
Regulation Number
890.5720
GUDID distribution status
In Commercial Distribution

Other devices from Shanghai Youwen Medical Technology Co., Ltd.

See all devices from Shanghai Youwen Medical Technology Co., Ltd. →

Properties

  • Premarket Exempt
  • Lot / Batch Number

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
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No