# K192249: InMode System with Tone Applicator

- Pathway: 510(k) (Traditional)
- Applicant: InMode, Ltd.
- Decided: Dec 17, 2019 after 120 days
- Product code: IPF (Stimulator, Muscle, Powered)
- 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 K945509 (1995). 5 ancestors in all.
9 later devices descend from it; 2 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132284: Vectra Neo Clinical Therapy System, Djo, LLC (2014) Summary page 4.

## Most influential descendants
- K201285: InMode Evolve System with the Tone Applicator (2021), 6 descendants of its own
- K210877: Evolve System with the T3 Applicator (2021), 5 descendants of its own
- K241433: EVE Synergy (EVE-20M) (2025), 1 descendant of its own
- K202079: Physiq (2020), 1 descendant of its own
- K253542: Apollo Quattro (APQ-10M) (2026), 0 descendants of its own

## Indications for use
The InMode System with Tone Applicator is used in EMS mode for: Prevention or retardation of disuse atrophy Maintaining or increasing range of motion Muscle re-education Relaxation of muscle spasms Increasing local blood circulation Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis And in TENS mode for: Symptomatic relief and management of chronic, intractable pain Post-surgical acute pain Post-traumatic acute pain

Source page: https://510kreport.com/device/K192249
Methodology: https://510kreport.com/methodology