# K131190: Mypatch

- Pathway: 510(k) (Traditional)
- Applicant: Dms-Service, LLC
- Decided: Oct 29, 2013 after 186 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: 3 generations back to K950944 (1996). 5 ancestors in all.
15 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)
- K113862: Zio Patch, iRhythm Technologies, Inc. (2012) Summary page 1.
- K113176: Mysense Heart, Cardiac Science Corporation (2011) Summary page 1.

## Cited in the summary but kept off the family tree
- K923664: Scole 300 Ecg Recorder, Scole Engineering Co. (1994). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K160704: myPatch-s (2016), 14 descendants of its own
- 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

## Indications for use
The myPatch 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.

Source page: https://510kreport.com/device/K131190
Methodology: https://510kreport.com/methodology