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FDA 510(k)

Flyte Mechanotherapy System, MTI-1.5 (MTI-1.5)

K-Number: K240805 · 2024-08-01

ApplicantPelvital USA, Inc.
Decision Date2024-08-01
Product CodeHIR
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Flyte Mechanotherapy System, MTI-1.5 (MTI-1.5) is a medical device manufactured by Pelvital USA, Inc.. It received FDA 510(k) clearance on 2024-08-01 under approval number K240805. 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, MTI-1.5 (MTI-1.5)?

Flyte Mechanotherapy System, MTI-1.5 (MTI-1.5) is a medical device that received FDA 510(k) clearance on 2024-08-01. It is manufactured by Pelvital USA, Inc.. The 510(k) number is K240805.

When was Flyte Mechanotherapy System, MTI-1.5 (MTI-1.5) approved by the FDA?

Flyte Mechanotherapy System, MTI-1.5 (MTI-1.5) received FDA 510(k) clearance on 2024-08-01, under approval number K240805.

What company makes Flyte Mechanotherapy System, MTI-1.5 (MTI-1.5)?

Flyte Mechanotherapy System, MTI-1.5 (MTI-1.5) is manufactured by Pelvital USA, Inc..

What is the FDA product code for Flyte Mechanotherapy System, MTI-1.5 (MTI-1.5)?

The FDA product code for Flyte Mechanotherapy System, MTI-1.5 (MTI-1.5) is HIR.

Other Devices by Pelvital USA, Inc.

K200409Pelvital System K212655Flyte K210764Flyte K233362Flyte Mechanotherapy System (aka Flyte System) (MTI-1.0)

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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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