# K240347: PTG-05

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer Medizinsysteme GmbH
- Decided: Jul 21, 2024 after 167 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: 4 generations back to K062439 (2007). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212866: truSculpt flex, Johari Digital Healthcare Limited (2022) Summary page 5.

## Indications for use
* Improvement of abdominal tone, for strengthening of the abdominal muscles, for development of firmer abdomen. * Strengthening, toning, and firming of buttocks & thighs. * Strengthening, toning, and firming of arms.

Source page: https://510kreport.com/device/K240347
Methodology: https://510kreport.com/methodology