S-Patch Ex Wearable ECG Patch
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K231289 FDA 510(k)
- FDA Product Code
- DSH FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.2800 FDA 510(k)
- Regulation Number
- 870.2800 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The S-Patch Ex Wearable ECG Patch is a wearable electrocardiogram (ECG) monitoring device designed for continuous, non-invasive cardiac rhythm assessment. It records electrical activity of the heart to detect arrhythmias, ischemia, or other cardiac abnormalities in ambulatory patients.
This single-use, adhesive ECG patch is intended for home or clinical use and connects wirelessly to a recorder for data transmission. Supplied sterile and packaged individually, it adheres to Class II regulatory standards under FDA 510(k) clearance and MDD compliance. No MRI safety restrictions are specified, and the device requires no special storage beyond standard room temperature.
Frequently asked questions
Is the S-Patch Ex Wearable ECG Patch designed for use in a hospital setting, or is it primarily intended for home monitoring by patients?
The S-Patch Ex Wearable ECG Patch is designed for both home and clinical use, allowing continuous, non-invasive cardiac rhythm assessment in ambulatory patients. Its wireless connectivity and single-use, sterile packaging make it suitable for convenient monitoring in either environment.
How is the S-Patch Ex Wearable ECG Patch supplied, and what should I consider regarding its sterility and reusability?
The S-Patch Ex Wearable ECG Patch is supplied sterile and packaged individually, ensuring single-use only. This design eliminates the need for reprocessing and reduces the risk of contamination, making it ideal for both clinical and home use without requiring special handling beyond standard storage conditions.
Does the S-Patch Ex Wearable ECG Patch require any special storage conditions, or can it be kept at room temperature?
No special storage conditions are required for the S-Patch Ex Wearable ECG Patch. It can be stored at standard room temperature, simplifying logistics for both healthcare providers and patients.
What types of cardiac abnormalities can the S-Patch Ex Wearable ECG Patch detect, and how does it transmit the recorded data?
The S-Patch Ex Wearable ECG Patch records electrical activity of the heart to detect arrhythmias, ischemia, or other cardiac abnormalities. It connects wirelessly to a recorder for data transmission, enabling continuous monitoring without the need for wired connections.
Are there any restrictions on using the S-Patch Ex Wearable ECG Patch in environments with magnetic resonance imaging (MRI) machines?
The device data does not specify any MRI safety restrictions for the S-Patch Ex Wearable ECG Patch, meaning it should not inherently interfere with MRI procedures. However, it is always recommended to verify compatibility with the specific MRI system and follow facility guidelines to ensure patient safety.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K231289 | Class II | Active |
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Manufacturer
- Manufacturer
- Wellysis Corp.
Sources (2)
- FDA 510(k) K231289 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026