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FDA PMA

Wearable automated external defibrillator

PMA Number: P010030 · 2026-05-15

ApplicantZoll Manufacturing Corporation
Decision Date2026-05-15
PMA NumberP010030
Product CodeMVK
Device ClassClass 3
Medical SpecialtyU
Advisory CommitteeCV

Device Summary

Wearable automated external defibrillator is a medical device manufactured by Zoll Manufacturing Corporation. It received FDA Premarket Approval (PMA) on 2026-05-15 under PMA number P010030. The device is classified under FDA product code MVK. It was reviewed by the CV advisory panel. This device is classified as Class III by the FDA. Class III devices subject to the most stringent regulatory controls. These devices generally require premarket approval (PMA) because they support or sustain human life, are of substantial importance in preventing impairment of human health, or present a potential unreasonable risk of illness or injury. PMA is the most stringent type of device marketing application required by the FDA. The device falls under the medical specialty of U. Unlike 510(k) clearance, which demonstrates substantial equivalence to a predicate device, PMA requires the manufacturer to submit clinical trial data demonstrating the safety and effectiveness of the device. PMA is generally required for Class III devices that support or sustain human life, are of substantial importance in preventing impairment of human health, or present a potential unreasonable risk of illness or injury.

Frequently Asked Questions

What is Wearable automated external defibrillator?

Wearable automated external defibrillator is a medical device that received FDA Premarket Approval (PMA) on 2026-05-15. It is manufactured by Zoll Manufacturing Corporation. The PMA number is P010030.

When did Wearable automated external defibrillator receive FDA PMA approval?

Wearable automated external defibrillator received FDA PMA approval on 2026-05-15, under approval number P010030.

What company makes Wearable automated external defibrillator?

Wearable automated external defibrillator is manufactured by Zoll Manufacturing Corporation.

What is the difference between PMA and 510(k)?

PMA (Premarket Approval) is the FDA process for evaluating Class III medical devices. Unlike 510(k) clearance, which demonstrates substantial equivalence to a predicate device, PMA requires the manufacturer to provide clinical data proving safety and effectiveness. PMA is the most stringent type of device marketing application required by the FDA.

What is the FDA product code for Wearable automated external defibrillator?

The FDA product code for Wearable automated external defibrillator is MVK.

What FDA device class is Wearable automated external defibrillator?

Wearable automated external defibrillator is classified as Class III by the FDA.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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