# K002830: Pelvic Muscle Therapy

- Pathway: 510(k) (Traditional)
- Applicant: Colonial Medical Supply
- Decided: Dec 27, 2000 after 107 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
No predicates in its family tree.
9 later devices descend from it; 4 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K021115: Gyneflex (2002), 4 descendants of its own
- K141893: Vibrance Kegel Device (VKD) (2014), 2 descendants of its own
- K121902: Natratone (2013), 2 descendants of its own
- K171896: Feminine Personal Trainer (FPT) (2017), 1 descendant of its own
- K162689: Vibrance Pelvic Trainer (2017), 1 descendant of its own

Source page: https://510kreport.com/device/K002830
Methodology: https://510kreport.com/methodology