# K212495: Leva Pelvic Health System

- Pathway: 510(k) (Special)
- Applicant: Renovia, Inc.
- Decided: Sep 8, 2021 after 30 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: 5 generations back to K891774 (1989). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192270: LEva Pelvic Digital Health System, Renovia, Inc. (2019) Summary page 4.

## Most influential descendants
- K213913: leva Pelvic Health System (2022), 0 descendants of its own

## Indications for use
The leva Pelvic Health System is intended for: 1) Strengthening of the pelvic floor muscles; 2) Rehabilitation and training of weak pelvic floor muscles for the treatment of stress, mixed and mild to moderate urgency urinary incontinence (including overactive bladder) in women. This device interacts with the user via smart phone technology.

Source page: https://510kreport.com/device/K212495
Methodology: https://510kreport.com/methodology