# K133990: Ieva Rehabilitative Positional Device

- Pathway: 510(k) (Traditional)
- Applicant: Remendium Labs, LLC
- Decided: Oct 9, 2014 after 286 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 K891774 (1989). 2 ancestors in all.
4 later devices descend 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)
- K013653: Incare Pressure Biofeedback Vaginal Pressure Probe and Anal Pressure Probe, Hollister, Inc. (2002) Summary page 4.

## Most influential descendants
- K180637: leva Pelvic Floor Trainer (2018), 3 descendants of its own
- K192270: LEva Pelvic Digital Health System (2019), 2 descendants of its own
- K212495: Leva Pelvic Health System (2021), 1 descendant of its own
- K213913: leva Pelvic Health System (2022), 0 descendants of its own

## Indications for use
The Ieva Pelvic Floor Trainer is intended for the purpose of rehabilitation and training of weak pelvic floor muscles for the treatment of stress, mixed and mild- moderate urge incontinence in women. This device interacts with the user via smart phone technology.

Source page: https://510kreport.com/device/K133990
Methodology: https://510kreport.com/methodology