# K240805: Flyte Mechanotherapy System, MTI-1.5 (MTI-1.5)

- Pathway: 510(k) (Traditional)
- Applicant: Pelvital USA, Inc.
- Decided: Aug 1, 2024 after 129 days
- Product code: HIR (Perineometer)
- Device class: 2
- Regulation: 21 CFR 884.1425
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K212655 (2021). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K233362: Flyte Mechanotherapy System (aka Flyte System) (MTI-1.0), Pelvital USA, Inc. (2023) Summary page 5.

## Indications for use
The Flyte System is intended for strengthening of the pelvic floor muscles to treat women with mild, moderate, and severe stress urinary incontinence

Source page: https://510kreport.com/device/K240805
Methodology: https://510kreport.com/methodology