# K171410: ePatch

- Pathway: 510(k) (Traditional)
- Applicant: Braemar Manufacturing, LLC
- Decided: Jan 4, 2018 after 234 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: 5 generations back to K950944 (1996). 7 ancestors in all.
7 later devices descend from it; 3 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160704: myPatch-s, Dms-Service, LLC (2016) Summary page 4.
- K131190: Mypatch, Dms-Service, LLC (2013) Summary page 4.

## Most influential descendants
- K231289: S-Patch Ex Wearable ECG Patch (2023), 3 descendants of its own
- K211709: Biotres (2022), 2 descendants of its own
- K253384: mobiCARE Cardiac Monitoring System (mobiCARE-MC200M, mobiCARE-MC200ML, mobiCARE-MC200M7, mobiCARE-MC200ML7) (2026), 0 descendants of its own
- K252389: Rhythm Master ECG Patch (HM-15BB-AX, HM-15BW-AX, HM-15BW-DX) (2026), 0 descendants of its own
- K233864: ASSURE Wearable ECG (2024), 0 descendants of its own

## Indications for use
The ePatch® 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 ePatch® is intended for use by adolescents 18-21 and adults.

Source page: https://510kreport.com/device/K171410
Methodology: https://510kreport.com/methodology