Jewel Patch Wearable Cardioverter Defibrillator (P-WCD) (Jewel)
FDA PMAClass III (US FDA PMA)
Identity
- Trade Name
- Jewel Patch Wearable Cardioverter Defibrillator (P-WCD) (Jewel), Jewel P-WCD Firmware, Device Accessories Skin Preparati FDA PMA
- Generic Name
- Wearable automated external defibrillator FDA PMA
Identifiers
- PMA Number
- P230022 FDA PMA
- FDA Product Code
- MVK FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Cardiovascular FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The Jewel Patch Wearable Cardioverter Defibrillator (P-WCD) is a Class III wearable automated external defibrillator designed to deliver life-saving electrical therapy for patients experiencing sudden cardiac arrest. It is intended for adult patients aged 18 and older who are at risk of sudden cardiac arrest but are not candidates for or refuse an implantable defibrillator. The device continuously monitors heart rhythms and delivers shocks when ventricular tachycardia or ventricular fibrillation is detected.
The Jewel P-WCD is supplied with firmware updates, skin preparation accessories, placement and removal kits, and optional software accessories including the ES Mobile Application, ES Cloud, ES Report Generator, and ES Clinical Portal. It is intended for single-use per patient and requires FDA approval (PMA P230022). The device is not MRI-safe and must be stored according to manufacturer instructions to maintain functionality and sterility.
Frequently asked questions
What is the Jewel Patch Wearable Cardioverter Defibrillator (P-WCD) designed to do for patients at risk of sudden cardiac arrest?
The Jewel P-WCD is a wearable automated external defibrillator intended to continuously monitor heart rhythms in adult patients aged 18 and older who are at risk of sudden cardiac arrest but are not candidates for or refuse an implantable defibrillator. It delivers life-saving electrical therapy—such as shocks—when it detects life-threatening arrhythmias like ventricular tachycardia or ventricular fibrillation.
Is the Jewel P-WCD intended for reuse, or is it single-use per patient?
The Jewel P-WCD is explicitly intended for **single-use per patient**. After use, it should not be reused, as this could compromise its functionality and safety. The manufacturer’s instructions must be followed for proper disposal.
What software and accessories come included with the Jewel P-WCD, and how are they used?
The Jewel P-WCD is supplied with firmware updates, skin preparation accessories, and placement/removal kits. Optional software accessories include the **ES Mobile Application**, **ES Cloud**, **ES Report Generator**, and **ES Clinical Portal**, which are designed for monitoring, data management, and clinical reporting. These tools help clinicians track patient data and manage device performance remotely.
How should the Jewel P-WCD be stored to maintain its functionality and sterility?
The device must be stored according to the manufacturer’s instructions to preserve functionality and sterility. While specific storage conditions (e.g., temperature, humidity) aren’t detailed here, the manufacturer’s guidelines—likely included in the packaging or user manual—must be strictly followed to ensure the device remains operational and safe for use.
What regulatory pathway was followed for the Jewel P-WCD’s approval, and what does this mean for clinicians?
The Jewel P-WCD was approved via the **FDA Premarket Approval (PMA) pathway (PMA P230022)**, a rigorous process for Class III devices. This means the device has undergone extensive clinical testing and review to ensure its safety and effectiveness for its intended use in adult patients at risk of sudden cardiac arrest who are not candidates for or refuse an implantable defibrillator.
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 (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P230022 | Class III | Active |
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Manufacturer
- Manufacturer
- Element Science, Inc.
Sources (1)
- FDA PMA P230022 24 fields · synced Sep 18, 2026