Data / Medical devices / Wearable Automated External Defibrillator
Wearable Automated External Defibrillator (MVK): 10 FDA-registered makers in 1 country
10 establishments in 1 country are registered with the FDA to make Wearable Automated External Defibrillator (product code MVK, Class 3). 4 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 0 510(k) clearances under this code, and lists 5 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- MVK
- Device class
- 3
- Medical specialty
- Unknown
- Life sustaining or supporting
- Yes
Makers by country
| Country | Makers |
|---|---|
| United States | 10 |
Makers of Wearable Automated External Defibrillator
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Element Science, Inc. | Redwood City, CA, United States | Complaint file establishment, Manufacturer, Specification developer | 0 | 1 | 0 | 0 | api.fda.gov | |
| KESTRA Medical Technologies, Inc. | Kirkland, WA, United States | Complaint file establishment, Specification developer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Zoll Medical Corporation | Chelmsford, MA, United States | Manufacturer | 0 | 1 | 0 | 0 | api.fda.gov | |
| ZOLL Manufacturing Corporation | Pittsburgh, PA, United States | Manufacturer | 0 | 1 | 5 | 0 | api.fda.gov | |
| Benchmark Electronics, Inc. | Winona, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Katecho LLC | Des Moines, IA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Polo Custom Products | Monticello, IA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Phillips-Medisize Costa Mesa LLC | Costa Mesa, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Technical Services For Electronics, Inc. | Jackson, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ZOLL Medical Corporation | Pawtucket, RI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.