MVK

Wearable Automated External Defibrillator

Product code: MVK
Device name: Wearable Automated External Defibrillator
Device class: Class 3
Medical specialty: Unknown
Marketing pathway: PMA
Flag: Life-sustaining / life-supporting

FDA classification definition

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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

Official FDA classification page: MVK

Classification and pathway per current FDA publications. Data from openFDA (CC0).