Flyte Mechanotherapy System (aka Flyte System) (MTI-1.0)— 510(k) K233362

Substantially Equivalent

Pelvital USA, Inc.

FDA 510(k) clearance K233362 for Flyte Mechanotherapy System (aka Flyte System) (MTI-1.0), Substantially Equivalent on 2023-12-29. Applicant: Pelvital USA, Inc..

Clearance details

Applicant: Pelvital USA, Inc.
Product code: Code HIR
Advisory panel: Obstetrics/Gynecology
Date received: 2023-10-02
Decision date: 2023-12-29
Decision: Substantially Equivalent
Clearance type: Special
Location: Eagan, MN, US

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