# K170637: sensiFirm

- Pathway: 510(k) (Traditional)
- Applicant: El Global Trade, Ltd.
- Decided: Jul 14, 2017 after 134 days
- Product code: PBX (Massager, Vacuum, Radio Frequency Induced Heat)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 20 generations back to K943450 (1995). 314 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 318 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160329: InMode System MiniFX Handpiece, Inmode MD, Ltd. (2016) Summary page 4.
- K150035: V10 system, Viora, Ltd. (2015) Summary page 4.

## Most influential descendants
- K181095: RF-Relief (2018), 1 descendant of its own
- K250734: OptiLUV Device (2025), 0 descendants of its own
- K214015: Palm NRG cellulite body device (model: Palm NRG body device) (2022), 0 descendants of its own

## Indications for use
The sensiFirm device is intended for the treatment of the following medical conditions using non thermal RF combined with massage: Temporary reduction in the appearance of cellulite.

Source page: https://510kreport.com/device/K170637
Methodology: https://510kreport.com/methodology