# K213913: leva Pelvic Health System

- Pathway: 510(k) (Traditional)
- Applicant: Renovia, Inc.
- Decided: Jun 30, 2022 after 197 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: 6 generations back to K891774 (1989). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212495: Leva Pelvic Health System, Renovia, Inc. (2021) Summary page 4.

## 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; 3) Rehabilitation and training of weak pelvic floor muscles for the first-line treatment of chronic fecal incontinence (>3-month uncontrolled passage of feces) in women. This device interacts with the user via smart phone technology.

Source page: https://510kreport.com/device/K213913
Methodology: https://510kreport.com/methodology