Tenscare Kegelfit Pelvic Floor Exerciser - The Kegelfit is intended to provide electrical - TENSCARE LIMITED

Duns Number:569403736

Device Description: The Kegelfit is intended to provide electrical stimulation and neuromuscular re-education 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: KPIRegulation Number: 21 CFR 876.5320Regulatory Class: II

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More Product Details

Catalog Number

K-KEGEL

Brand Name

Tenscare Kegelfit Pelvic Floor Exerciser

Version/Model Number

KegelFit2

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

KPI

Product Code Name

Stimulator, Electrical, Non-Implantable, For Incontinence

Device Record Status

Public Device Record Key

52a1f9a7-1c8b-4c5a-8af7-5e81d0228b9f

Public Version Date

July 19, 2018

Public Version Number

1

DI Record Publish Date

June 18, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"TENSCARE LIMITED" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 7