# K253408: CoolTone

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer Medizinsysteme GmbH
- Decided: Jan 16, 2026 after 108 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: 10 generations back to K010335 (2001). 47 ancestors in all.
No later device cites it as a predicate yet.
0 of 48 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K240234: BTL-899MS, BTL Industries, Inc. (2024) Summary page 5.

## Indications for use
CoolTone device is indicate 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 When intended to stimulate healthy muscles to improve or facilitate muscle performance, CoolTone induces muscle contractions to enhance muscle function and may therefore be considered a technique of muscle training. In addition, the CoolTone is indicated to be used for: * Relaxation of muscle spasms . Prevention or retardation of disuse atrophy . Increasing local blood circulation . Muscle reeducation . Maintaining or increasing the range of motion CoolTone may also be used under medical supervision for adjunctive therapy for the treatment of medical diseases and conditions. Furthermore, CoolTone device may be used to stimulate neuromuscular tissue for bulk muscle excitation in the legs for rehabilitative purposes.

Source page: https://510kreport.com/device/K253408
Methodology: https://510kreport.com/methodology