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Pelvifine KM500

by Shenzhen Konmed Technology Co., Ltd.

Pelvifine KM500 is a Class II device made by Shenzhen Konmed Technology Co., Ltd., listed in FDA GUDID since 18 Feb 2025 (UDI-DI 06970935830710), registry data as of 22 Oct 2026.

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

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number06970935830710 UDI-DI Date18 Feb 2025ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
Pelvifine
Generic name
Pelvic floor muscle exerciser
Model / reference
KM500
Primary DI / UDI-DI
06970935830710
FDA product code
KXQ
GMDN term
Pelvic floor muscle exerciser
Device class
Class II
Regulation number
884.5960
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code KXQ (Vibrator For Therapeutic Use, Genital).

Other devices from Shenzhen Konmed Technology Co., Ltd.

See all devices from Shenzhen Konmed Technology Co., Ltd. →

Properties

  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (12, all answered No)