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Sound Options Tinnitus Treatment 2.0

by Sound Options Tinnitus Treatments, Inc.

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 Number00627843723226 UDI-DI Date23 Feb 2017ListedStatusListed 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  • Withdrawn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
Sound Options Tinnitus Treatment
Generic Name
Tinnitus masking application software
Model / Reference
2.0
Primary DI / UDI-DI
00627843723226
FDA Product Code
KLW
GMDN Term
Tinnitus masking application software
Device Class
Class II
Regulation Number
874.3400
GUDID distribution status
In Commercial Distribution

Other devices from Sound Options Tinnitus Treatments, Inc.

Properties

  • Premarket Exempt
  • Lot / Batch Number
  • Serial Number
  • Manufacturing Date

Other properties (10)

  • 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
  • Expiration Date: No