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FDA 510(k)

leva Pelvic Floor Trainer

K-Number: K180637 · 2018-04-04

ApplicantRenovia, Inc.
Decision Date2018-04-04
Product CodeHIR
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

leva Pelvic Floor Trainer is a medical device manufactured by Renovia, Inc.. It received FDA 510(k) clearance on 2018-04-04 under approval number K180637. 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 leva Pelvic Floor Trainer?

leva Pelvic Floor Trainer is a medical device that received FDA 510(k) clearance on 2018-04-04. It is manufactured by Renovia, Inc.. The 510(k) number is K180637.

When was leva Pelvic Floor Trainer approved by the FDA?

leva Pelvic Floor Trainer received FDA 510(k) clearance on 2018-04-04, under approval number K180637.

What company makes leva Pelvic Floor Trainer?

leva Pelvic Floor Trainer is manufactured by Renovia, Inc..

What is the FDA product code for leva Pelvic Floor Trainer?

The FDA product code for leva Pelvic Floor Trainer is HIR.

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Other Devices by Renovia, Inc.

K192270LEva Pelvic Digital Health System K212495Leva Pelvic Health System K213913leva Pelvic Health System

Related Devices (Code: HIR)

K160758PeriCoach OTCAnalytica, Ltd. K171896Feminine Personal Trainer (FPT)Ralston Group K162689Vibrance Pelvic TrainerBioinfinity (M) Sdn. Bhd. K192270LEva Pelvic Digital Health SystemRenovia, Inc. K193364Intimate Rose Kegel Exercise SystemPlus EV Holdings Dba Intimate Rose K200409Pelvital SystemPelvital USA, Inc.

Official Source

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

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