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…

Registry build 21.09.26

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 incontinence in women. The Kegelfit is a powered muscle stimulator used for strengthening the pelvic floor muscles. It sends a gentle stimulation (similar to your natural nerve impulses) direct to your pelvic floor muscles through a vaginal Trainer with stainless steel electrodes. These signals make your pelvic floor muscle contract. If you have forgotten how to contract your pelvic floor, are having trouble getting muscle response, or simply want to bring back the condition of your pelvic floor muscles, the Kegelfit can work them for you to build up their strength and help you to develop your own muscle control. It perfectly complements pelvic floor exercises. The kegelfit is very easy to use, with two preset training programs, two choices of exercise time and simple push button control. Stimulator, Electrical, Non-implantable, for Incontinence → Title 21, Code of Federal Regulations Sec.876.5320 ProCode: KPI Regulation Number: 21 CFR 876.5320 Regulatory Class: II

7manufacturers in China registered for this device type
1catalogue number
4510(k) clearances naming this product code

Who Else Makes It

Concentrated in Guangdong (6), Jiangsu (1).

Chinese manufacturers registered for FDA product code KPI
Manufacturer City Province Registered as Device types
Shenzhen Dongdixin Technology Co., Ltd. Shenzhen Guangdong Contract manufacturer 18
Shenzhen MED-Link Electronics Tech Co., Ltd. Shenzhen Guangdong Contract manufacturer 18
Netop Industrial Company Limited Dongguan Guangdong Manufacturer 14
Shenzhen Changkun Technology Co., Ltd. Shenzhen Guangdong Contract manufacturer 11
Shenzhen Konmed Technology Co., Ltd. Shenzhen Guangdong Contract manufacturer 8
Easymed Instruments Co., Ltd. Daliang, Shunde, Foshan Guangdong Contract manufacturer 8
Dolanvy (Suzhou) Medical Technology Co., Ltd. Suzhou Jiangsu Manufacturer 3

Record

Regulatory record for Tenscare Kegelfit Pelvic Floor Exerciser
Listed by Tenscare Ltd., United Kingdom
FDA product code KPI
Device type Stimulator, Electrical, Non-Implantable, For Incontinence
Device class Class 2
Regulation 21 CFR 876.5320
Establishment Specification developer, Repacker / relabeller, Private-label distributor, Manufacturer, Exporter
Record published 2018-06-18

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Over the counter Yes
Label carries serial number

Catalogue Numbers

Catalogue numbers for Tenscare Kegelfit Pelvic Floor Exerciser
Catalogue number Size Status
KegelFit2 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Lifecare Everyway Medical Instruments Co., Ltd. 28
EMC Evolution EMC Evolution 10
Konmed Shenzhen Konmed Technology Co., Ltd. 8
DLR Dolanvy (Suzhou) Medical Technology Co., Ltd. 8
iSTIM Everyway Medical Instruments Co., Ltd. 7
Pathway® Prometheus Group OF NEW Hampshire Limited, THE 6
Everyway Everyway Medical Instruments Co., Ltd. 5
Liberty Utah Medical Products, Inc. 4
TensCare Tenscare Ltd. 4
BTL Chair Applicator Btl Industries, Ltd. 3
NeoControl Magic Race LLC 3
Konmed /Pelvifine Shenzhen Konmed Technology Co., Ltd. 3

Showing 12 of 42. All products under Stimulator, Electrical, Non-Implantable, For Incontinence

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K230983 2023-10-20
K191312 2019-11-01
K142506 2015-04-20
K103698 2011-06-21

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

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