Pelvic Muscle Trainer

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref 04Model KM518

by Shenzhen Konmed Technology Co., Ltd.

Identity

Trade Name: Pelvic Muscle Trainer EUDAMED
KONMED /K-fit/pelvifine FDA UDI
Generic Name: Perineal orifice incontinence-control electrical stimulation system FDA UDI
Device Name: Pelvic Muscle Trainer EUDAMED
Pelvic Health Device is one of a new breed of modern Neuromuscular Stimulators (STIM) developed with the aim of achieving optimum pelvic health for women. Our principle aim is to design a product to give women the opportunity to exercise their muscles, strengthen weak muscles and nerve fibres in a compact, easy to use device - we also wanted the device to be able to be versatile enough so that as a woman achieve greater muscle control, with high levels of functional use, are sensibly priced, compact and user friendly. FDA UDI
Model / Reference: KM518 EUDAMEDFDA UDI
04 EUDAMED
Description: Pelvic Health Device is one of a new breed of modern Neuromuscular Stimulators (STIM) developed with the aim of achieving optimum pelvic health for women. Our principle aim is to design a product to give women the opportunity to exercise their muscles, strengthen weak muscles and nerve fibres in a compact, easy to use device - we also wanted the device to be able to be versatile enough so that as a woman achieve greater muscle control, with high levels of functional use, are sensibly priced, compact and user friendly. FDA UDI

Identifiers

Primary DI / UDI-DI: 06970935830017 EUDAMEDFDA UDI
Basic UDI-DI: B-06970935830017 EUDAMED
510(k) Number: K163288 FDA UDI
FDA Product Code: KPI FDA UDI
EMDN Code: U070399 PELVIC FLOOR REHABILITATION DEVICES - OTHER EUDAMED
GMDN Term: Perineal orifice incontinence-control electrical stimulation system FDA UDI

Classification

Device Class: Class IIa EUDAMED
Class II FDA UDI
Regulation Number: 876.5320 FDA UDI
Market of Registration: Italy EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

EUDAMEDFDA UDI

Single Use

FDA UDI

Implantable

EUDAMEDFDA UDI

Reusable

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

Prescription Use

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Pelvic Muscle Trainer by Shenzhen Konmed Technology Co., Ltd. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDD

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/MDD	B-06970935830017	Class IIa	Active
FDA UDI	United States	FDA UDI	Registered in GUDID	Class IIa	Pending data

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Manufacturer

Manufacturer: Shenzhen Konmed Technology Co., Ltd.
EUDAMED SRN: CN-MF-000018375
Authorised Representative: Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Sources (2)

EUDAMED 4f3f3d87-9d5f-49d6-af0a-c4ad6d640d09 61 fields · synced May 30, 2026
FDA UDI aaa555d9-d8bc-4a96-8194-058a5941e618 34 fields · synced May 30, 2026