AccessGUDID - DEVICE: KONMED /Pelvifine (06970935830543)

GUDID

Device Identifier (DI) Information

Brand Name: KONMED /Pelvifine
Version or Model: KM531
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Shenzhen Konmed Technology Co., Ltd.

Primary DI Number: 06970935830543
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 544436531 *Terms of Use

Device Description: This Biofeedback Nerve and Muscle Stimulator is a new type of biofeedback and neuromuscular electrical stimulation therapy device through the evaluation of myoelectric signal acquisition, multimedia biofeedback training, electromyography triggered electrical stimulation, passive electrical stimulation training and treatment.

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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):	Yes
Over the Counter (OTC):	No
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?
64427	Pelvic floor exercise biofeedback device	An electrically-powered, home-use device intended to be inserted into the anus to visualize/measure the consciously-controlled contraction force of the pelvic floor muscles, to facilitate the self-training of pelvic floor exercises for improved control of bowel function in patients affected by anal/faecal incontinence and/or constipation; it is not a muscle exerciser. It may wirelessly transmit data to a smartphone app for display/recording. This is a single-patient, reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IPF	Stimulator, Muscle, Powered
KPI	Stimulator, Electrical, Non-Implantable, For Incontinence
HCC	Device, Biofeedback

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K202648	000

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: e909fa65-a1dd-4c01-9836-9fd40aa865d7
Public Version Date: November 02, 2021
Public Version Number: 1
DI Record Publish Date: October 25, 2021