Data / Medical devices / Over-The-Counter Automated External Defibrillator
Over-The-Counter Automated External Defibrillator (NSA): 5 FDA-registered makers in 3 countries
5 establishments in 3 countries are registered with the FDA to make Over-The-Counter Automated External Defibrillator (product code NSA, Class 3, 21 CFR 870.5310). 2 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 1 510(k) clearance under this code, the latest on September 16, 2004, and lists 2 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- NSA
- Device class
- 3
- Regulation
- 870.5310
- Medical specialty
- Cardiovascular
- Life sustaining or supporting
- Yes
Makers by country
| Country | Makers |
|---|---|
| United States | 3 |
| Mexico | 1 |
| United Kingdom | 1 |
Makers of Over-The-Counter 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 |
|---|---|---|---|---|---|---|---|---|
| Philips North America LLC | Bothell, WA, United States | Manufacturer | 0 | 1 | 2 | 0 | api.fda.gov | |
| Philips North America LLC | Woodinville, WA, United States | Manufacturer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Greatbatch Medical S. de R.L. de C.V. | Tijuana Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Heartsine Technologies, Ltd | BELFAST Northern Ireland, United Kingdom | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Katecho LLC | Des Moines, IA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated September 16, 2004. 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.