510(k) K233362

Flyte Mechanotherapy System (aka Flyte System) (MTI-1.0) by Pelvital USA, Inc. — Product Code HIR

K233362 is an FDA 510(k) premarket notification submitted by Pelvital USA, Inc. for the device "Flyte Mechanotherapy System (aka Flyte System) (MTI-1.0)". The FDA issued a decision of Substantially Equivalent on December 29, 2023. The device falls under product code HIR (Perineometer), a Class II device regulated under 21 CFR 884.1425. Pelvital USA, Inc. has at least 4 other 510(k) clearances on record.