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Relaxis 09-0021-02RN

by Relaxis

Listed FDA GUDID listing, not in commercial distribution

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 Number00852335007076 UDI-DI Date22 Sep 2016ListedStatusListed GUDID: not 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  • Withdrawn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
Relaxis
Generic Name
Restless legs syndrome vibratory counterstimulation system
Model / Reference
09-0021-02RN
Primary DI / UDI-DI
00852335007076
FDA Product Code
OVP
GMDN Term
Restless legs syndrome vibratory counterstimulation system
Device Class
Class II
Regulation Number
882.5895
GUDID distribution status
Not in Commercial Distribution

Properties

  • Prescription Use
  • Lot / Batch Number
  • Serial Number

Other properties (11)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Expiration Date: No
  • Manufacturing Date: No