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Equate LY-ET-01

by Jiangxi Royall Smart Technology Co., Ltd.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 22 Oct 2026

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 Number06972759470004 UDI-DI Date29 Jun 2023ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Equate
Generic Name
Physical therapy transcutaneous neuromuscular electrical stimulation system
Model / Reference
LY-ET-01
Primary DI / UDI-DI
06972759470004
510(k) Number
FDA Product Code
NYN, NGX, NUH
GMDN Term
Physical therapy transcutaneous neuromuscular electrical stimulation system
Device Class
Class II
Regulation Number
882.5890, 890.5850
GUDID distribution status
In Commercial Distribution

Other devices from Jiangxi Royall Smart Technology Co., Ltd.

Properties

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