Product code
MVK: Wearable automated external defibrillator
FDA product code · Class III · Cardiovascular
Key facts
| Product code | MVK |
|---|---|
| Device | Wearable automated external defibrillator |
| Device class | Class III |
| Review panel | Cardiovascular |
| Submission type | PMA |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | Yes |
| 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. |
At a glance
- None 510(k) clearances
- None De Novo grants
- 1–9 PMA approvals
- None HDE approvals
- 10–99 UDI devices (GUDID)
- 1,000+ MAUDE adverse event reports
- 1–9 Recalled products (Z-numbers)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device product codes
FDA product codes classify medical devices by type and intended use; each code maps to a device class, a classification regulation and a review panel.
Source: U.S. Food and Drug Administration (FDA), Product Classification database