Skip to content

Wave Wav-01

by Hush Tech LLC

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00860012112500 UDI-DI Date1 Sep 2024ListedStatusListed 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  • Withdrawn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
Wave
Generic Name
Pelvic floor internal manual massager
Model / Ref / Catalog
WAV-01
Primary DI / UDI-DI
00860012112500
FDA Product Code
KXQ
GMDN Term
Pelvic floor internal manual massager
Device Class
Class II
Regulation Number
884.5960
GUDID distribution status
In Commercial Distribution

Related devices

Category: Pelvic floor internal manual massager

Properties

  • Over-the-Counter
  • Premarket Exempt
  • Lot / Batch Number

Other properties (11)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No