Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 the device name listed in this FDA 510(k) record. The listed applicant is Pelvital USA, Inc.. It received FDA 510(k) clearance on 2024-08-01 under 510(k) 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. The listed applicant is Pelvital USA, Inc.. The 510(k) number is K240805.

When did Flyte Mechanotherapy System, MTI-1.5 (MTI-1.5) receive FDA 510(k) clearance?

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

Who is the listed applicant for Flyte Mechanotherapy System, MTI-1.5 (MTI-1.5)?

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, MTI-1.5 (MTI-1.5)?

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

K233362Flyte Mechanotherapy System (aka Flyte System) (MTI-1.0)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.K231875Vaginal Tactile Ultrasound ImagerAdvanced Tactile Imaging, Inc.K233362Flyte Mechanotherapy System (aka Flyte System) (MTI-1.0)Pelvital USA, Inc.K231780Perifit Care+X6 InnovationsK221476PerifitX6 InnovationsK213913leva Pelvic Health SystemRenovia, 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.

↑