Devices · Element Science, Inc.

Jewel Patch Wearable Cardioverter Defibrillator (P-WCD) (Jewel), Jewel P-WCD Firmware, Device Accessories Skin Preparati

Element Science, Inc. is listed for Jewel Patch Wearable Cardioverter Defibrillator (P-WCD) (Jewel), Jewel P-WCD Firmware, Device Accessories Skin Preparati (P230022). The FDA list gives April 30, 2025 as the date of the final decision. The lead panel is Cardiovascular, and the database link on the FDA list is the PMA pathway. openFDA describes product code MVK as “Wearable Automated External Defibrillator”: The device is an automatic external defibrillator which monitors and treats a patient for ventricular defibrillation. Device is intended to be worn in home or in hospital settings as prescribed and overseen by a physician. This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P230022

Official FDA database record

Date of final decision

April 30, 2025

Company on the FDA list

Element Science, Inc.

Lead panel

Cardiovascular

Primary product code

MVK

openFDA device name for the code

Wearable Automated External Defibrillator

Device class

3

Regulation number

Not returned

openFDA decision description

Not returned

openFDA decision code

Not returned

Statement or summary label

Not returned