KONMED /Pelvifine

GUDID 06970935830536

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.

Shenzhen Konmed Technology Co., Ltd.

Pelvic floor exercise biofeedback device
Primary Device ID06970935830536
NIH Device Record Key59c5f98f-1f67-4104-bbdf-400111326782
Commercial Distribution StatusIn Commercial Distribution
Brand NameKONMED /Pelvifine
Version Model NumberKM530
Company DUNS544436531
Company NameShenzhen Konmed Technology Co., Ltd.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106970935830536 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IPFStimulator, Muscle, Powered

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-11-02
Device Publish Date2021-10-25

On-Brand Devices [KONMED /Pelvifine]

06970935830543This Biofeedback Nerve and Muscle Stimulator is a new type of biofeedback and neuromuscular elec
06970935830536This Biofeedback Nerve and Muscle Stimulator is a new type of biofeedback and neuromuscular elec
06970935830598This Biofeedback device is a type of biofeedback and neuromuscular electrical stimulation therap
06970935830581This Biofeedback device is a type of biofeedback and neuromuscular electrical stimulation therap
06970935830574This Biofeedback device is a type of biofeedback and neuromuscular electrical stimulation therap
06970935830567This Biofeedback device is a type of biofeedback and neuromuscular electrical stimulation therap

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