PMA P230022

Device: Jewel Patch Wearable Cardioverter Defibrillator (P-WCD) (Jewel); Jewel P-WCD Firmware; Jewel Placement Accessory (Class
Applicant: Element Science, Inc.
Product code: MVK
Decision date: 2026-03-04
Generic name: Wearable automated external defibrillator
Approval order statement: approval for minor software modifications to the Jewel® Patch Wearable Cardioverter Defibrillator (P-WCD) and the optional Jewel Mobile App.

Current openFDA PMA Record#

Device: Jewel Patch Wearable Cardioverter Defibrillator (P-WCD) (Jewel); Jewel P-WCD Firmware; Jewel Placement Accessory (Class
Applicant: Element Science, Inc.
PMA number: P230022
Supplement: S003
Product code: MVK
Generic name: Wearable automated external defibrillator
Decision date: 2026-03-04
Decision code: APPR
Date received: 2025-10-01
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: approval for minor software modifications to the Jewel® Patch Wearable Cardioverter Defibrillator (P-WCD) and the optional Jewel Mobile App.