# K172381: Digitimer DS7AP Constant Current Stimulator

- Pathway: 510(k) (Traditional)
- Applicant: Digitimer, Ltd.
- Decided: Mar 6, 2018 after 211 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: 1 generation back to K980448 (1998). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980448: Model PS-1 Pena Muscle Stimulator, Radionics, Inc. (1998) Summary page 4.

## Most influential descendants
- K233098: MYOTouch Muscle Stimulator (2024), 0 descendants of its own

## Indications for use
The Digitimer DS7AP Constant Current Stimulator is indicated for use as an adjunct in the treatment of high and low anorectal malformations by helping in the identification of the striated muscles to be used in anal reconstructions.

Source page: https://510kreport.com/device/K172381
Methodology: https://510kreport.com/methodology