# K251594: truFlex

- Pathway: 510(k) (Special)
- Applicant: Syrma Johari Medtech Limited
- Decided: Aug 28, 2025 after 93 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: 11 generations back to K903402 (1990). 81 ancestors in all.
No later device cites it as a predicate yet.
0 of 82 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.
- K233926: accufit, Mettler Electronics Corporation (2024) Summary page 5.
- K240234: BTL-899MS, BTL Industries, Inc. (2024) Summary page 6.

## Indications for use
truFlex 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 arms, buttocks, thighs, and calves * Relaxation of muscle spasms * Prevention or retardation of disuse atrophy * Increasing local blood circulation * Muscle re-education * Maintaining or increasing range of motion * Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis * Stimulation of neuromuscular tissue for bulk muscle excitation in the legs or arms for rehabilitative purposes * To be used under medical supervision for adjunctive therapy for the treatment of medical diseases and conditions

Source page: https://510kreport.com/device/K251594
Methodology: https://510kreport.com/methodology