# K231289: S-Patch Ex Wearable ECG Patch

- Pathway: 510(k) (Traditional)
- Applicant: Wellysis Corp.
- Decided: Aug 30, 2023 after 118 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: 6 generations back to K950944 (1996). 8 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171410: ePatch, Braemar Manufacturing, LLC (2018) Summary page 4.

## Most influential descendants
- 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
- K233906: S-Patch  (S-Patch ExL) (2024), 0 descendants of its own

## Indications for use
S-Patch Ex wearable ECG patch 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. S-Patch Ex wearable ECG patch is intended for use by patients 18 years or older.

Source page: https://510kreport.com/device/K231289
Methodology: https://510kreport.com/methodology