# K213655: HiTop® (Models: HiToP®4touch, HiToP®2touch, HiToP®1touch)

- Pathway: 510(k) (Traditional)
- Applicant: Hilltek, LLC
- Decided: Jan 17, 2023 after 424 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: 6 generations back to K001179 (2000). 12 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113017: Sys*Stim 240, Mettler Electronics Corp. (2012) Summary page 4.

## Most influential descendants
- K252816: High Tone Power therapy (HiToP) (Model: HiToP PNP) (2026), 0 descendants of its own

## Indications for use
HiToP®4touch, HiToP®2touch, and HiToP®1touch is intended to be used as Powered muscle stimulator • Relaxation of muscle spasms • Increase local blood circulation • Muscle re-education • Maintaining or increasing range of motion TENS • Symptomatic relief and management of chronic, intractable pain

Source page: https://510kreport.com/device/K213655
Methodology: https://510kreport.com/methodology