# K122800: Inner Peace

- Pathway: 510(k) (Traditional)
- Applicant: Kamabry, Inc., Dba Inner Peace For Women
- Decided: Oct 4, 2013 after 387 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 K002830 (2000). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021115: Gyneflex, Naissance Holdings, LC (2002) Summary page 1.
- K002830: Pelvic Muscle Therapy, Colonial Medical Supply (2000) Summary page 1.
- K023305: Kegelmaster 2000, Kegelmaster 2000, Ltd. (2002) Summary page 1.

## Indications for use
The Inner Peace pelvic exercise device is recommended for the strengthening of perincal pelvic floor muscles by offering resistance to an individual's voluntary contractions of these muscles. It seeks to correct, through exercise, urinary incontinence in women.

Source page: https://510kreport.com/device/K122800
Methodology: https://510kreport.com/methodology