K-number	K233362
Device name	Flyte Mechanotherapy System (aka Flyte System) (MTI-1.0)
Applicant	Pelvital USA, Inc.
Product code	HIR
Device class	Class II
Decision date	Dec 29, 2023
Decision	Substantially Equivalent
Regulation	884.1425

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View the full FDA submission: accessdata.fda.gov

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Flyte Mechanotherapy System (aka Flyte System) (MTI-1.0)

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