Cardiovascular · PMA · 2025
Jewel Patch Wearable Cardioverter Defibrillator (P-WCD) (Jewel), Jewel P-WCD Firmware, Device Accessories Skin Preparati
Element Science, Inc.. Approved by FDA on 30 April 2025 under submission P230022, product code MVK (wearable automated external defibrillator). What FDA's record says, in FDA's words.
Device record · P230022
- Device. Jewel Patch Wearable Cardioverter Defibrillator (P-WCD) (Jewel), Jewel P-WCD Firmware, Device Accessories Skin PreparatiDEVICE
- Company. Element Science, Inc.COMPANY
- Decision. 30 April 2025, PMA, apprDECISION
- Panel. CardiovascularPANEL
- Product code. MVK, Wearable Automated External DefibrillatorCODE
- Source. FDA database entry · decision document (38 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA approved it for
The Indications for Use statement, verbatim, from the decision document.
. Probable benefits are more than minimal. Probable risks appear to be the same or less than with other approved wearable cardioverter defibrillator devices. Considering the limited sample size, rarity of events, and use of AI/ML, a robust post market study is necessary to confirm performance.
The product code's definition, from FDA's classification record. 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.
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Mentionsnone of the tracked terms matched
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 150,940 reports filed against devices carrying product code MVK. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification. The latest reports, in the reporter’s words:
30 September 2026 · Injury · LifeVest WCD 4000 System · ZOLL Manufacturing Corporation · report 3008642652-2026-09492
A patient received an inappropriate shock. SVT contributed to the false detection. The response buttons were pressed during the event.The patient continues to wear LV.
30 September 2026 · Injury · LifeVest WCD 5100 System · ZOLL Manufacturing Corporation · report 3008642652-2026-09493
A patient received 2 inappropriate shocks.SVT contributed to the false detection.The response buttons were pressed during the event.The patient continues wearing LifeVest.
30 September 2026 · Injury · LifeVest WCD 4000 System · ZOLL Manufacturing Corporation · report 3008642652-2026-09494
A patient received 2 inappropriate shocks. AF with RVR contributed to the false detection. The response buttons were pressed after the event.The patient continues wearing LifeVest.
30 September 2026 · Malfunction · LifeVest WCD 4000 System · ZOLL Manufacturing Corporation · report 3008642652-2026-09495
A US distributor reported that a battery was unable to power on a monitor.
30 September 2026 · Malfunction · LifeVest WCD 4000 System · ZOLL Manufacturing Corporation · report 3008642652-2026-09496
A US distributor reported that a battery was unable to power on a monitor.
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code MVK, in Cardiovascular, or approved in 2025. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.