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KONMED /Pelvifine

FDA UDI

Class II (US FDA UDI)

by Shenzhen Konmed Technology Co., Ltd.

Identity

Trade Name
KONMED /Pelvifine FDA UDI
Generic Name
Perineal orifice incontinence-control electrical stimulation system, home-use FDA UDI
Device Name
This Biofeedback device is a type of biofeedback and neuromuscular electrical stimulation therapy device for patients with pelvic floor muscle dysfunction through the evaluation of myoelectric signal acquisition, multimedia biofeedback training, electromyography triggered electrical stimulation, passive electrical stimulation training and treatment.The device is intended to provide electrical stimulation and neuromuscular re-education for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of stress, urge and mixed urinary incontinence in women and to maintain urinary continence in women. FDA UDI
Model / Reference
KM537 FDA UDI
Description
This Biofeedback device is a type of biofeedback and neuromuscular electrical stimulation therapy device for patients with pelvic floor muscle dysfunction through the evaluation of myoelectric signal acquisition, multimedia biofeedback training, electromyography triggered electrical stimulation, passive electrical stimulation training and treatment.The device is intended to provide electrical stimulation and neuromuscular re-education for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of stress, urge and mixed urinary incontinence in women and to maintain urinary continence in women. FDA UDI

Identifiers

Primary DI / UDI-DI
06970935830598 FDA UDI
510(k) Number
K220161 FDA UDI
FDA Product Code
KPI FDA UDI
HCC FDA UDI
GMDN Term
Perineal orifice incontinence-control electrical stimulation system, home-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.5320 FDA UDI
882.5050 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Perineal orifice incontinence-control electrical stimulation system, home-use

KONMED /Pelvifine by Shenzhen Konmed Technology Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Perineal orifice incontinence-control electrical stimulation system, home-use.

Cleared under the same submission

K220161 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Shenzhen Konmed Technology Co., Ltd.

Sources (1)

  • FDA UDI e84b148d-a5c8-4a6e-95bb-f4a085737af0 34 fields · synced May 30, 2026