# K212866: truSculpt flex

- Pathway: 510(k) (Traditional)
- Applicant: Johari Digital Healthcare Limited
- Decided: Dec 3, 2022 after 451 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: 3 generations back to K062439 (2007). 3 ancestors in all.
7 later devices descend from it; 3 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192039: Torc Body, Johari Digital Healthcare Limited (2020) Summary page 4.

## Most influential descendants
- K232455: SofWave System (2023), 4 descendants of its own
- K240687: SofWave System (2024), 3 descendants of its own
- K241685: SofWave System (2024), 2 descendants of its own
- K250146: SofWave System (2025), 1 descendant of its own
- K251594: truFlex (2025), 0 descendants of its own

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

Source page: https://510kreport.com/device/K212866
Methodology: https://510kreport.com/methodology