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510(k) Data Aggregation
K Number
K141893Device Name
VIBRANCE KEGEL DEVICE (VKD)
Manufacturer
BIOINFINITY (M)SDN.BHD.
Date Cleared
2014-12-18
(157 days)
Product Code
HIR
Regulation Number
884.1425Why did this record match?
Applicant Name (Manufacturer) :
BIOINFINITY (M)SDN.BHD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Vibrance Kegel Device (VKD) is intended for the strengthening of the pelvic floor muscles, which has been found to help women with urinary incontinence.
Device Description
The Vibrance Kegel Device (VKD700) is an intra-vaginal exercise device intended to strengthen the pelvic floor musculature by offering resistance to an individual's voluntary contractions of these muscles. The Vibrance Kegel Device incorporates an active vibration biofeedback mechanism for the identification of the pelvic floor muscles, and the sheaths provide graduated resistance levels for the progressive strengthening of the pelvic floor muscle.
The therapeutic effect is from the user using the device to exercise the pelvic floor muscles in accordance with the exercise program included in the instructions. The device provides biofeedback information that allows the user to verify the use of the correct muscles in the exercise routine and thus the effectiveness of the exercises undertaken. The device also includes a resistive component to the training program to strengthen the pelvic floor muscle via physiologic principles. The biofeedback mechanism works by directly sensing the force applied by the pelvic floor muscle.
The device consists of a Main Body and three Resistance Sheaths with varying degrees of stiffness. It has a PCB assembly, and is battery powered by two independent 3V CR 1220 Lithium Batteries operating on two independent, enclosed electronic circuits for the vibration biofeedback loop and the other for audio guided training. The maximum diameter of the Vibrance Kegel Device shaft is 2.4 cm. The maximum inserted length of the shaft is 6 cm.
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