1 device · 1 company · 2025
Product code MVK: Wearable Automated External Defibrillator
1 device under product code MVK, 2025, from 1 company. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (1 of 1 here), the regulation, and MAUDE report counts by product code.
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. MAUDE held 150,940 adverse-event reports against this product code as of 2026-10-29; reports are unverified and the code is shared by every device of this type.
Retrieved from FDA public records.
Every device, newest decision first
| Decision | Device | Company | Panel | FDA |
|---|---|---|---|---|
| Jewel Patch Wearable Cardioverter DefibrillatorP230022 · PMA | Element Science, Inc. | Cardiovascular | database entry |
Every product code in the record, the whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.