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Upper Limb Rehabilitation Training System AG01

by Shanghai ZDROID 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 Number06979351820015 UDI-DI Date23 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  • Withdrawn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
Upper Limb Rehabilitation Training System
Generic Name
Virtual-display rehabilitation system, powered-support, upper-limb
Model / Reference
AG01
Primary DI / UDI-DI
06979351820015
FDA Product Code
IKK
GMDN Term
Virtual-display rehabilitation system, powered-support, upper-limb
Device Class
Class II
Regulation Number
890.1925
GUDID distribution status
In Commercial Distribution
Sterilization Method
High-level Disinfectant

Properties

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