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FDA 510(k)

Vibrance Pelvic Trainer

K-Number: K162689 · 2017-06-08

ApplicantBioinfinity (M) Sdn. Bhd.
Decision Date2017-06-08
Product CodeHIR
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Vibrance Pelvic Trainer is a medical device manufactured by Bioinfinity (M) Sdn. Bhd.. It received FDA 510(k) clearance on 2017-06-08 under approval number K162689. The device is classified under product code HIR. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Vibrance Pelvic Trainer?

Vibrance Pelvic Trainer is a medical device that received FDA 510(k) clearance on 2017-06-08. It is manufactured by Bioinfinity (M) Sdn. Bhd.. The 510(k) number is K162689.

When was Vibrance Pelvic Trainer approved by the FDA?

Vibrance Pelvic Trainer received FDA 510(k) clearance on 2017-06-08, under approval number K162689.

What company makes Vibrance Pelvic Trainer?

Vibrance Pelvic Trainer is manufactured by Bioinfinity (M) Sdn. Bhd..

What is the FDA product code for Vibrance Pelvic Trainer?

The FDA product code for Vibrance Pelvic Trainer is HIR.

Related Devices (Code: HIR)

K160758PeriCoach OTCAnalytica, Ltd. K171896Feminine Personal Trainer (FPT)Ralston Group K180637leva Pelvic Floor TrainerRenovia, Inc. K192270LEva Pelvic Digital Health SystemRenovia, Inc. K193364Intimate Rose Kegel Exercise SystemPlus EV Holdings Dba Intimate Rose K200409Pelvital SystemPelvital USA, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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