Wearable Automated External Defibrillator

FDA product classification. Device class 3. Review panel CV.

Classification

Each row is one field of the openFDA record. The grey name is the field’s name in openFDA’s documentation.

Field	Value	Field name
Product code	MVK	product_code
Device name	Wearable Automated External Defibrillator	device_name
Device class	3	device_class
Review panel	CV	review_panel
Regulation number	empty	regulation_number
Medical specialty	Unknown	medical_specialty

Source: FDA openFDA, device/classification, product code MVK, as held in ArrHub’s controlled vocabulary with its citation. Public domain (CC0).

PMA records with this code

Every verified record ArrHub holds under the code, newest first.

Decision	Applicant	Device	Record
2026-07-30	Zoll Manufacturing Corporation	LifeVest® Wearable Defibrillator	P010030/S202 FDA
2026-07-16	Kestra Medical Technologies, Inc.	ASSURE Wearable Cardioverter Defibrillator system (ASSURE system)	P200037/S020 FDA
2026-05-15	Zoll Manufacturing Corporation	LifeVest® Wearable Defibrillator	P010030/S200 FDA
2026-04-14	Kestra Medical Technologies, Inc.	ASSURE Wearable Cardioverter Defibrillator (WCD) System	P200037/S019 FDA
2026-03-06	Kestra Medical Technologies, Inc.	ASSURE Wearable Cardioverter Defibrillator (WCD) System	P200037/S018 FDA
2026-03-04	Element Science, Inc.	Jewel Patch Wearable Cardioverter Defibrillator (P-WCD) (Jewel); Jewel P-WCD Firmware; Jewel Placement Accessory (Class (truncated in the FDA record)	P230022/S003 FDA
2026-01-29	Zoll Manufacturing Corporation	LifeVest® Wearable Defibrillator	P010030/S199 FDA
2026-01-13	Element Science, Inc.	Jewel Patch Wearable Cardioverter Defibrillator (P-WCD) (Jewel), Jewel P-WCD Firmware, Device Accessories Skin Preparati (truncated in the FDA record)	P230022/S006 FDA
2025-04-30	Element Science, Inc.	Jewel Patch Wearable Cardioverter Defibrillator (P-WCD) (Jewel), Jewel P-WCD Firmware, Device Accessories Skin Preparati (truncated in the FDA record)	P230022 FDA
2021-07-27	Kestra Medical Technologies, Inc.	ASSURE Wearable Cardioverter Defibrillator (WCD) System	P200037 FDA
2001-12-18	Zoll Manufacturing Corporation	WEARABLE CARDIOVERTER DEFIBRILLATOR (WCD) 2000 LIFEVEST	P010030 FDA

510(k) clearances with this code

Every verified record ArrHub holds under the code, newest first.

None in the verified view.

ArrHub

What ArrHub adds to the record. Everything above this line is the agency’s; everything here is ArrHub’s, dated and attributed.

ArrHub vocabulary

Electrophysiology

MVK is one of the 56 product codes in ArrHub’s electrophysiology vocabulary, each held with its FDA classification record as its citation. Vocabulary entry verified 20 September 2026.

Raw record

The stored record exactly as ArrHub holds it, for anyone who wants to check the page against it.

Show the raw record (JSON)device/classification.json?search=product_code:MVK

{
  "id": "fda_product_code:MVK",
  "vocabulary": "fda_product_code",
  "term": "MVK",
  "definition": "Wearable Automated External Defibrillator",
  "attrs": {
    "device_class": "3",
    "review_panel": "CV",
    "medical_specialty": "Unknown",
    "regulation_number": ""
  },
  "jurisdiction": "US",
  "authority": "FDA",
  "ep_relevant": true,
  "source_url": "https://api.fda.gov/device/classification.json?search=product_code:MVK",
  "verified_by": "Bruno Deslauriers",
  "verified_at": "2026-09-20T01:22:27.524165+00:00",
  "notes": "Fetched from https://open.fda.gov/apis/device/classification/",
  "created_at": "2026-09-20T01:19:26.94253+00:00",
  "updated_at": "2026-09-20T01:19:12.658+00:00"
}

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