# K160704: myPatch-s

- Pathway: 510(k) (Traditional)
- Applicant: Dms-Service, LLC
- Decided: Jul 15, 2016 after 123 days
- Product code: DSH (Recorder, Magnetic Tape, Medical)
- Device class: 2
- Regulation: 21 CFR 870.2800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K950944 (1996). 6 ancestors in all.
14 later devices descend from it; 2 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131190: Mypatch, Dms-Service, LLC (2013) Summary page 5.

## Most influential descendants
- K171410: ePatch (2018), 7 descendants of its own
- K163535: my Patch sl (2017), 5 descendants of its own
- K231289: S-Patch Ex Wearable ECG Patch (2023), 3 descendants of its own
- K211709: Biotres (2022), 2 descendants of its own
- K210758: Q Patch (2022), 1 descendant of its own

## Indications for use
myPatch®s is indicated for use on patients who may be asymptomatic or who may suffer from transient symptoms such as palpitations, shortness of breath, dizziness, light headedness, pre-syncope, syncope, fatigue, chest pain and/or anxiety. The myPatch®s is intended for use by Adults and all Pediatric subgroups.

Source page: https://510kreport.com/device/K160704
Methodology: https://510kreport.com/methodology