# K233362: Flyte Mechanotherapy System (aka Flyte System) (MTI-1.0)

- Pathway: 510(k) (Special)
- Applicant: Pelvital USA, Inc.
- Decided: Dec 29, 2023 after 88 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: 1 generation back to K212655 (2021). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212655: Flyte, Pelvital USA, Inc. (2021) Summary page 4.

## Most influential descendants
- K240805: Flyte Mechanotherapy System, MTI-1.5 (MTI-1.5) (2024), 0 descendants of its own

## Indications for use
The Flyte System is intended for strengthening of the pelvic floor muscles to treat women with stress urinary incontinence.

Source page: https://510kreport.com/device/K233362
Methodology: https://510kreport.com/methodology