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FDA 510(k)

Flyte Mechanotherapy System (aka Flyte System) (MTI-1.0)

K-Number: K233362 · 2023-12-29

ApplicantPelvital USA, Inc.
Decision Date2023-12-29
Product CodeHIR
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Flyte Mechanotherapy System (aka Flyte System) (MTI-1.0) is a medical device manufactured by Pelvital USA, Inc.. It received FDA 510(k) clearance on 2023-12-29 under approval number K233362. 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 Flyte Mechanotherapy System (aka Flyte System) (MTI-1.0)?

Flyte Mechanotherapy System (aka Flyte System) (MTI-1.0) is a medical device that received FDA 510(k) clearance on 2023-12-29. It is manufactured by Pelvital USA, Inc.. The 510(k) number is K233362.

When was Flyte Mechanotherapy System (aka Flyte System) (MTI-1.0) approved by the FDA?

Flyte Mechanotherapy System (aka Flyte System) (MTI-1.0) received FDA 510(k) clearance on 2023-12-29, under approval number K233362.

What company makes Flyte Mechanotherapy System (aka Flyte System) (MTI-1.0)?

Flyte Mechanotherapy System (aka Flyte System) (MTI-1.0) is manufactured by Pelvital USA, Inc..

What is the FDA product code for Flyte Mechanotherapy System (aka Flyte System) (MTI-1.0)?

The FDA product code for Flyte Mechanotherapy System (aka Flyte System) (MTI-1.0) is HIR.

Other Devices by Pelvital USA, Inc.

K200409Pelvital System K212655Flyte K210764Flyte K240805Flyte Mechanotherapy System, MTI-1.5 (MTI-1.5)

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K160758PeriCoach OTCAnalytica, Ltd. K171896Feminine Personal Trainer (FPT)Ralston Group K162689Vibrance Pelvic TrainerBioinfinity (M) Sdn. Bhd. K180637leva Pelvic Floor TrainerRenovia, Inc. K192270LEva Pelvic Digital Health SystemRenovia, Inc. K193364Intimate Rose Kegel Exercise SystemPlus EV Holdings Dba Intimate Rose

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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