Skip to content

Pelvic Muscle Trainer KM516B

by Shenzhen Konmed Technology Co., Ltd.

Pelvic Muscle Trainer KM516B is a Class II device made by Shenzhen Konmed Technology Co., Ltd., cleared under FDA 510(k) K260178 on 18 Jun 2026 and listed in FDA GUDID since 8 Jul 2026 (UDI-DI 06970935830635), active as of 22 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K260178

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number06970935830635 UDI-DI Date8 Jul 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK260178 Date18 Jun 2026DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K260178 decided 18 Jun 2026 Active
  • FDA GUDID UDI-DI 06970935830635 listed 8 Jul 2026 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K260178
  2. Listed FDA GUDID 06970935830635

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Pelvic Muscle Trainer
Generic name
Perineal orifice incontinence-control electrical stimulation system, home-use
Model / reference
KM516B
Primary DI / UDI-DI
06970935830635
510(k) Number
FDA product code
KPI
GMDN term
Perineal orifice incontinence-control electrical stimulation system, home-use
Device class
Class II
Regulation number
876.5320
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Related devices

Cleared under the same submission (K260178)

Similar devices

Other devices filed under FDA product code KPI (Stimulator, Electrical, Non-Implantable, For Incontinence).

Other devices from Shenzhen Konmed Technology Co., Ltd.

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

Properties

  • Over-the-counter
  • Lot / batch number
  • Serial number
  • Expiration date
  • Manufacturing date
Other properties (10, all answered No)