# K233098: MYOTouch Muscle Stimulator

- Pathway: 510(k) (Traditional)
- Applicant: Sunmed, LLC
- Decided: Aug 2, 2024 after 311 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: 2 generations back to K980448 (1998). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172381: Digitimer DS7AP Constant Current Stimulator, Digitimer, Ltd. (2018) Summary page 4.

## Indications for use
The MYOTouch Muscle Stimulator is indicated for use as an adjunct in the treatment of high and low anorectic malformations by helping with the identification of striated muscles to be used in anal reconstructions. The MYOTouch device is intended for use by trained personnel who are competent to apply the appropriate stimuli.

Source page: https://510kreport.com/device/K233098
Methodology: https://510kreport.com/methodology