FDA product code MVK: Wearable Automated External Defibrillator
MVK is the FDA product code for wearable automated external defibrillator. It is a Class III device, reviewed by the Cardiovascular panel. Devices under MVK reach the market by PMA; FDA lists no cleared 510(k)s for it. 3 PMA applications cite this product code. FDA has posted 5 recalls for MVK devices.
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.
Classification
| Field | Value |
|---|---|
| Device name | Wearable Automated External Defibrillator |
| Device class | Class III |
| Review panel | CV — Cardiovascular |
| Medical specialty | Unknown |
| Premarket route | PMA |
| Life-sustaining or supporting | Yes |
Recalls for MVK devices
5 product recalls in 5 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2017-09-12.
| Year | Recalls |
|---|---|
| 2017 | 1 |
Frequently asked questions
What is FDA product code MVK?
MVK is the FDA product code for wearable automated external defibrillator. It is a Class III device, reviewed by the Cardiovascular panel.
What device class is MVK?
Class III. Typical premarket route: PMA.
Have MVK devices been recalled?
Yes: 5 product recalls across 5 recall events; the most recent began 2017-09-12.
Next steps
- Run an FDA pathway report with predicate devices for product code MVK
- Run a recall and safety report across every MVK manufacturer
- Watch product code MVK for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All Cardiovascular product codes · FDA product code lookup · 510(k) database search · 510(k) review times