# K251378: CoolTone

- Pathway: 510(k) (Special)
- Applicant: Zimmer Medizinsysteme GmbH
- Decided: Jul 14, 2025 after 73 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: 7 generations back to K062439 (2007). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220601: CoolTone, Zimmer Medizinsysteme GmbH (2022) Summary page 5.

## Indications for use
. 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/K251378
Methodology: https://510kreport.com/methodology