Data / Medical devices / Board, Cardiopulmonary
Board, Cardiopulmonary (FOA): 10 FDA-registered makers in 3 countries
10 establishments in 3 countries are registered with the FDA to make Board, Cardiopulmonary (product code FOA, Class 1, 21 CFR 880.6080). 1 of them has a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 3 510(k) clearances under this code, the latest on July 29, 2022, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- FOA
- Device class
- 1
- Regulation
- 880.6080
- Medical specialty
- General Hospital
Makers by country
| Country | Makers |
|---|---|
| China | 5 |
| United States | 4 |
| Mexico | 1 |
Makers of Board, Cardiopulmonary
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 |
|---|---|---|---|---|---|---|---|---|
| Resuscitation Innovations LLC dba AdvancedCPR Solutions | Edina, MN, United States | Complaint file establishment, Specification developer | 1 | July 29, 2022 | 0 | 0 | 0 | api.fda.gov |
| Dragon Medical Co.,Ltd | Suzhou City Jiangsu, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Intermetro Industries Corp | Wilkes Barre, PA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| InterMetro de Acuna | Acuna Coahuila, Mexico | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangsu Rixin Medical Equipment Co., Ltd | Zhangjiagang Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kentron Health Care, Inc. | Springfield, TN, United States | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Teleflex Medical LLC | Morrisville, NC, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhangjiagang Jiekang Medical Equipment Co.,ltd | Zhangjiagang Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhangjiagang New Fellow Med Co., Ltd. | Zhangjiagang Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ZJG Royaltrust Med Co., Ltd. | Zhangjiagang City Jiangsu, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated July 29, 2022. 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.