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Pelvic Muscle Trainer

by Shenzhen Konmed Technology Co., Ltd.

Ref 04Model KM518

Pelvic Muscle Trainer (04) is a medical device (EU MDD Class IIa; FDA Class II; FDA product code KPI, Stimulator, Electrical, Non-Implantable, For Incontinence; EMDN category pelvic floor rehabilitation devices) made by Shenzhen Konmed Technology Co., Ltd., registered in EUDAMED on 24 Aug 2023 (Basic UDI-DI B-06970935830017), cleared under FDA 510(k) K163288 on 18 Jan 2018 and listed in FDA GUDID since 24 Jan 2018 (UDI-DI 06970935830017), active as of 22 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K163288

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-06970935830017 Basic UDI-DI 06970935830017UDI-DIDate24 Aug 2023RegisteredStatusActive
United StatesGUDID listing GUDID Number06970935830017 UDI-DI Date24 Jan 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK163288 Date18 Jan 2018DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-06970935830017 registered 24 Aug 2023 Active
  • FDA 510(k) K163288 decided 18 Jan 2018 Active
  • FDA GUDID UDI-DI 06970935830017 listed 24 Jan 2018 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K163288
  2. Listed FDA GUDID 06970935830017
  3. Registered EUDAMED B-06970935830017

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Pelvic Muscle Trainer EUDAMED
KONMED /K-fit/pelvifine GUDID
Generic name
Perineal orifice incontinence-control electrical stimulation system
Model / reference
KM518, 04
Primary DI / UDI-DI
06970935830017
Basic UDI-DI
B-06970935830017
510(k) Number
FDA product code
KPI
EMDN code
U070399 Pelvic floor rehabilitation devices - other
GMDN term
Perineal orifice incontinence-control electrical stimulation system
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
876.5320
System or procedure pack
System which is a device in itself
EU registration type
Legacy device (under a directive)
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Manufacturer details

EUDAMED SRN
CN-MF-000018375
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Similar devices in this category

Other devices filed under PELVIC FLOOR REHABILITATION DEVICES - OTHER.

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
  • Manufacturing date
Other properties (19, all answered No)