Data / Medical devices / China / Jiangsu Synecoun Medical Technology Co., Ltd.
Jiangsu Synecoun Medical Technology Co., Ltd.: FDA-registered device maker in Taizhou City Jiangsu, China, 2 510(k) clearances
Jiangsu Synecoun Medical Technology Co., Ltd. is registered with the FDA (registration 3017618673) in Taizhou City Jiangsu, China. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated November 18, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3017618673
- Address
- East of 1/2F, No. 50, G60, Eastside of Lujia Road, Westside of Koutai Road, CMC, Taizhou City Jiangsu, China, 225316
- Owner or operator
- Jiangsu Synecoun Medical Technology Co., Ltd. (10078260)
- Roles
- Manufacturer
- First device listed
- October 15, 2020
- Registered through
- 2026
- Brand names listed
- Pulsar Flow, SyneCare 1000 Deep Vein Thrombosis Prevention Therapy System, SyneCare 1100 Deep Vein Thrombosis Prevention Therapy System, Synectube
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Apparatus, Suction, Single Patient Use, Portable, Nonpowered | GCY | 1 | Manufacturer | accessdata.fda.gov |
| Sleeve, Limb, Compressible | JOW | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 18, 2021 | K211937 | SyneCare 1100 Deep Vein Thrombosis Prevention Therapy System | JOW | Substantially Equivalent | Jiangsu Synecoun Medical Technology Co., Ltd. | accessdata.fda.gov |
| April 2, 2021 | K203310 | SyneCare 1000 Deep Vein Thrombosis Prevention Therapy System | JOW | Substantially Equivalent | Jiangsu Synecoun Medical Technology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Apparatus, Suction, Single Patient Use, Portable, Nonpowered
- All makers of Sleeve, Limb, Compressible
Updated November 18, 2021. 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.