AccessGUDID - DEVICE: Tenscare Kegelfit Pelvic Floor Exerciser (05033435132089)

GUDID

Device Identifier (DI) Information

Brand Name: Tenscare Kegelfit Pelvic Floor Exerciser
Version or Model: KegelFit2
Commercial Distribution Status: In Commercial Distribution
Catalog Number: K-KEGEL
Company Name: TENSCARE LIMITED

Primary DI Number: 05033435132089
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 569403736 *Terms of Use

Device Description: 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

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
36784	Perineal orifice incontinence-control electrical stimulation system	An assembly of battery-powered devices designed to treat urinary and/or faecal incontinence through the application of electrical stimuli to the muscles of the pelvic floor. It consists of a pair of electrodes on a plug or pessary, and a pulse generator; it does not function by remote control. The plug or pessary is inserted into the rectum and/or the vagina to stimulate the pelvic floor muscles inducing Kegel-like contractions.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
KPI	Stimulator, Electrical, Non-Implantable, For Incontinence

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

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