Data / Medical devices / Device, Counter-Pulsating, External
Device, Counter-Pulsating, External (DRN): 7 FDA-registered makers in 3 countries
7 establishments in 3 countries are registered with the FDA to make Device, Counter-Pulsating, External (product code DRN, Class 2, 21 CFR 870.5225). 6 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 34 510(k) clearances under this code, the latest on December 22, 2025, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
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- Product code
- DRN
- Device class
- 2
- Regulation
- 870.5225
- Medical specialty
- Cardiovascular
Makers by country
| Country | Makers |
|---|---|
| China | 3 |
| United States | 3 |
| Singapore | 1 |
Makers of Device, Counter-Pulsating, External
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 |
|---|---|---|---|---|---|---|---|---|
| Chongqing Psk-Health Sci-Tech Development Co., Ltd | Chongqing, China | Manufacturer | 2 | December 12, 2013 | 0 | 0 | 0 | api.fda.gov |
| Renew Group Private Limited | Singapore Central Singapore, Singapore | Complaint file establishment, Manufacturer, Specification developer | 2 | December 17, 2015 | 0 | 0 | 0 | api.fda.gov |
| Vamed Medical Instrument Co.,ltd | Foshan Guangdong, China | Manufacturer | 2 | August 28, 2020 | 0 | 0 | 0 | api.fda.gov |
| Omay(guangzhou) Med Technologies Co., Ltd | Guangzhou Guangdong, China | Exporter to the US, Foreign private label distributor, Manufacturer, Repackager or relabeler | 1 | August 5, 2020 | 0 | 0 | 0 | api.fda.gov |
| Vasomedical, Inc. | Plainview, NY, United States | Manufacturer | 1 | March 1, 2004 | 0 | 0 | 0 | api.fda.gov |
| Xtreem Pulse | New York, NY, United States | Manufacturer, Specification developer | 1 | May 30, 2018 | 0 | 0 | 0 | api.fda.gov |
| S2 Equipment LLC | Farmington Hills, MI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated December 22, 2025. 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.