# K220601: CoolTone

- Pathway: 510(k) (Special)
- Applicant: Zimmer Medizinsysteme GmbH
- Decided: Apr 1, 2022 after 30 days
- Product code: NGX (Stimulator, Muscle, Powered, For Muscle Conditioning)
- Device class: 2
- Regulation: 21 CFR 890.5850
- 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 K062439 (2007). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192940: CoolTone, Zimmer Medizinsysteme GmbH (2019) Summary page 4.

## Most influential descendants
- K251378: CoolTone (2025), 0 descendants of its own

## Indications for use
CoolTone is indicated to be used for: * Improvement of abdominal tone, strengthening of the abdominal muscles, development for firmer abdomen. » Strengthening, toning and firming of buttocks and thighs.

Source page: https://510kreport.com/device/K220601
Methodology: https://510kreport.com/methodology