Stimulator, Electrical, Non-Implantable, for Incontinence

Which Manufacturers in China Make This?

7 manufacturers in China hold an FDA registration for this device type, based in Guangdong and Jiangsu.

Dolanvy (Suzhou) Medical Technology Co., Ltd. Jiangsu
Easymed Instruments Co., Ltd. Guangdong, contract manufacturer
Netop Industrial Company Limited Guangdong
Shenzhen Changkun Technology Co., Ltd. Guangdong, contract manufacturer
Shenzhen Konmed Technology Co., Ltd. Guangdong, contract manufacturer
Shenzhen MED-Link Electronics Tech Co., Ltd. Guangdong, contract manufacturer
Shenzhen Dongdixin Technology Co., Ltd. Guangdong, contract manufacturer

What Is FDA Product Code KPI?

Stimulator, Electrical, Non-Implantable, For Incontinence is FDA product code KPI, Class 2, 21 CFR 876.5320.

How Does It Reach the US Market?

A 510(k) premarket notification is required before it is sold in the United States: the applicant shows the device is substantially equivalent to one already on the market. The review can be done by an FDA-accredited third party, which is usually faster. Chinese applicants hold 17 clearances under this code; the FDA took a median of 217 days from receipt to decision on them.

Stimulator, Electrical, Non-Implantable, For Incontinence

Urostym EMG Cable, Ch 2

Catalogue number CAB906, listed by Laborie Medical Technologies Corp., United States, under Stimulator, Electrical, Non-Implantable, For Incontinence. 7 manufacturers in China are registered for this product code.

Stimulator, Electrical, Non-Implantable, For Incontinence

Yarlap I

The Yarlap® 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,…

Stimulator, Electrical, Non-Implantable, For Incontinence

InTone®MV

InToneMV

Stimulator, Electrical, Non-Implantable, For Incontinence

Levina

Levina RS-48 is a non-implantable, home-use pelvic floor muscle stimulator. The filing describes electrical stimulation through an intravaginal probe to the pelvic floor muscles. Its stated…

Stimulator, Electrical, Non-Implantable, For Incontinence

Richmar EMG Pro

Richmar EMG Pro Vaginal Probe

Stimulator, Electrical, Non-Implantable, For Incontinence

Urostym EMG Stimulation Cable, Ch 1

Catalogue number CAB896, listed by Laborie Medical Technologies Corp., United States, under Stimulator, Electrical, Non-Implantable, For Incontinence. 7 manufacturers in China are registered for this product code.

Stimulator, Electrical, Non-Implantable, For Incontinence

MyOnyx Mobile App

The MyOnyx Mobile App provides tablet-based remote access to the MyOnyx System during medically supervised treatment of urinary incontinence. It supports biofeedback, electrical stimulation…

Stimulator, Electrical, Non-Implantable, For Incontinence

Yarlap II

The Yarlap® 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,…

Stimulator, Electrical, Non-Implantable, For Incontinence

MFG-05

MFG-05 provides noninvasive electromagnetic stimulation of the pelvic floor muscles to treat urinary incontinence in adult men and women. It is intended to rehabilitate weak pelvic muscles…

Stimulator, Electrical, Non-Implantable, For Incontinence

Apex®M by Viveve

ApexM by Viveve

Stimulator, Electrical, Non-Implantable, For Incontinence

InWave

Electrotherapy device for treatment of urinary incontinence.

Stimulator, Electrical, Non-Implantable, For Incontinence

Intimd

Catalogue number KWELL EM1, listed by Everyway Medical Instruments Co., Ltd., Taiwan, under Stimulator, Electrical, Non-Implantable, For Incontinence. 7 manufacturers in China are registered for this product code.

Stimulator, Electrical, Non-Implantable, For Incontinence

Avazzia

Uro Probe, Regular

Stimulator, Electrical, Non-Implantable, For Incontinence

Apex®M

ApexM

Stimulator, Electrical, Non-Implantable, For Incontinence

Intrelief PFE

Intrelief PFE 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…

Stimulator, Electrical, Non-Implantable, For Incontinence

TensCare

The Kegelfit 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…

Stimulator, Electrical, Non-Implantable, For Incontinence

Pelvic Muscle Trainer

The Pelvic Muscle Trainer applies electrical stimulation to rehabilitate weak pelvic floor muscles in women with stress, urge or mixed urinary incontinence. It is a handheld home use system…

Stimulator, Electrical, Non-Implantable, For Incontinence

Attain

Catalogue number 3200000A1, listed by Incontrol Medical, LLC, United States, under Stimulator, Electrical, Non-Implantable, For Incontinence. 7 manufacturers in China are registered for this product code.

Stimulator, Electrical, Non-Implantable, For Incontinence

Liberty

Pelvic Floor Execiser System, Stimulator Unit, For use with Liberty execiser probes only, Includes Carrying Case, Batteries, and Instructional DVD

Stimulator, Electrical, Non-Implantable, For Incontinence

Tenscare Kegelfit Pelvic Floor Exerciser

The Kegelfit 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…

Stimulator, Electrical, Non-Implantable, For Incontinence

Konmed /Pelvifine

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…

Stimulator, Electrical, Non-Implantable, For Incontinence

DLR

8 catalogue numbers from DLR-8921, listed by Dolanvy (Suzhou) Medical Technology Co., Ltd., China, under Stimulator, Electrical, Non-Implantable, For Incontinence. 7 manufacturers in China are registered for this product code.

Stimulator, Electrical, Non-Implantable, For Incontinence

Konmed /k-Fit/pelvifine

The Pelvifine KM518 Pelvic Muscle Trainer is a nonimplanted electrical stimulator for treating stress, urge and mixed urinary incontinence in women. It stimulates the pelvic floor muscles…

Stimulator, Electrical, Non-Implantable, For Incontinence

HPM-6000U

2 catalogue numbers from HPM-6000U, listed by Btl Industries, Ltd., United States, under Stimulator, Electrical, Non-Implantable, For Incontinence. 7 manufacturers in China are registered for this product code.

Stimulator, Electrical, Non-Implantable, For Incontinence

iSTIM

7 catalogue numbers from iSTIM PR-02-2, listed by Everyway Medical Instruments Co., Ltd., Taiwan, under Stimulator, Electrical, Non-Implantable, For Incontinence. 7 manufacturers in China are registered for this product code.

Stimulator, Electrical, Non-Implantable, For Incontinence

NeoControl

Control Unit, 110 volt, NeoControl Pelvic Floor Therapy System

Stimulator, Electrical, Non-Implantable, For Incontinence

InTone®MV Nasp

InToneMV-NASP

Stimulator, Electrical, Non-Implantable, For Incontinence

MyOnyx

Catalogue number SA9020, listed by Thought Technology Ltd., Canada, under Stimulator, Electrical, Non-Implantable, For Incontinence. 7 manufacturers in China are registered for this product code.

Stimulator, Electrical, Non-Implantable, For Incontinence

Apex®

Apex

Stimulator, Electrical, Non-Implantable, For Incontinence

Everyway

5 catalogue numbers from PR-08A, listed by Everyway Medical Instruments Co., Ltd., Taiwan, under Stimulator, Electrical, Non-Implantable, For Incontinence. 7 manufacturers in China are registered for this product code.

Stimulator, Electrical, Non-Implantable, For Incontinence

Pathway®

Pathway® 6330 Vaginal EMG/Stimulation Sensor

Stimulator, Electrical, Non-Implantable, For Incontinence

Vtone Tip

Catalogue number AG608643A, listed by Inmode M.D Ltd, under Stimulator, Electrical, Non-Implantable, For Incontinence. 7 manufacturers in China are registered for this product code.

Stimulator, Electrical, Non-Implantable, For Incontinence

Neocontrol Pelvic Floor Therapy System, Incontinence Treatment Device

The device is intended to provide electrical stimulation and neuromuscular reeducation for the purpose of rehabilitation of weak pelvic Hoor muscles for the treatment of stress, urge and…

Stimulator, Electrical, Non-Implantable, For Incontinence

InTone®MV by Viveve

InToneMV by Viveve

Stimulator, Electrical, Non-Implantable, For Incontinence

Vtone Adapter HP

Catalogue number AG608649A, listed by Inmode M.D Ltd, under Stimulator, Electrical, Non-Implantable, For Incontinence. 7 manufacturers in China are registered for this product code.

Stimulator, Electrical, Non-Implantable, For Incontinence

BTL Chair Applicator

3 catalogue numbers from 899-AP-M-3, listed by Btl Industries, Ltd., United States, under Stimulator, Electrical, Non-Implantable, For Incontinence. 7 manufacturers in China are registered for this product code.

Stimulator, Electrical, Non-Implantable, For Incontinence

EMC Evolution

10 catalogue numbers from 112-B0-1-S, listed by EMC Evolution, under Stimulator, Electrical, Non-Implantable, For Incontinence. 7 manufacturers in China are registered for this product code.

Stimulator, Electrical, Non-Implantable, For Incontinence

HPM-6000U Applicator Chair

Catalogue number HPM-6000U Applicator Chair, listed by Btl Industries, Ltd., United States, under Stimulator, Electrical, Non-Implantable, For Incontinence. 7 manufacturers in China are registered for this product code.

Stimulator, Electrical, Non-Implantable, For Incontinence

Omnistim FX2 Continence Plus Portable

Non-implantable electrical stimulator for incontinence

Stimulator, Electrical, Non-Implantable, For Incontinence

EmbaGYN

EmbaGYN Pelvic Floor Exerciser is a portable, battery operated electrical muscle stimulator. EmbaGYN is indicated for the rehabilitation and strengthening of weak pelvic floor muscles in…

Stimulator, Electrical, Non-Implantable, For Incontinence

Lifecare

28 catalogue numbers from PR-20H, listed by Everyway Medical Instruments Co., Ltd., Taiwan, under Stimulator, Electrical, Non-Implantable, For Incontinence. 7 manufacturers in China are registered for this product code.

Stimulator, Electrical, Non-Implantable, For Incontinence

Konmed

The Konmed Incontinence Stimulation Electrode filing names vaginal probe models KM-503, KM-504, KM-505, KM-506, KM-507 and KM-5013, and rectal probe models KM-502 and KM-5018. These probes…

Stimulator, Electrical, Non-Implantable, For Incontinence

BTL Emsella

2 catalogue numbers from BTL EMSELLA, listed by Btl Industries, Ltd., United States, under Stimulator, Electrical, Non-Implantable, For Incontinence. 7 manufacturers in China are registered for this product code.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China

2,581device types they are registered for

340,248device records, each naming its maker

31provinces with a registered manufacturer