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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 the device name listed in this FDA 510(k) record. The listed applicant is Pelvital USA, Inc.. It received FDA 510(k) clearance on 2023-12-29 under 510(k) 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. The listed applicant is Pelvital USA, Inc.. The 510(k) number is K233362.

When did Flyte Mechanotherapy System (aka Flyte System) (MTI-1.0) receive FDA 510(k) clearance?

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

Who is the listed applicant for Flyte Mechanotherapy System (aka Flyte System) (MTI-1.0)?

The FDA 510(k) record lists Pelvital USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

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 records listing Pelvital USA, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K240805Flyte Mechanotherapy System, MTI-1.5 (MTI-1.5)K212655FlyteK210764FlyteK200409Pelvital System

Related Devices (Code: HIR)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252748Pelvic Floor Exerciser (PF01)Hunan Accurate Bio-Medical Technology Co., Ltd.K240805Flyte Mechanotherapy System, MTI-1.5 (MTI-1.5)Pelvital USA, Inc.K231875Vaginal Tactile Ultrasound ImagerAdvanced Tactile Imaging, Inc.K231780Perifit Care+X6 InnovationsK221476PerifitX6 InnovationsK213913leva Pelvic Health SystemRenovia, 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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