K203310 is an FDA 510(k) clearance for the SyneCare 1000 Deep Vein Thrombosis Prevention Therapy System. This device is classified as a Sleeve, Limb, Compressible (Class II - Special Controls, product code JOW).
Submitted by Jiangsu Synecoun Medical Technology Co., Ltd. (Taizhou, CN). The FDA issued a Cleared decision on April 2, 2021, 143 days after receiving the submission on November 10, 2020.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.5800.
| 510(k) Number | K203310 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 10, 2020 |
| Decision Date | April 02, 2021 |
| Days to Decision | 143 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | JOW - Sleeve, Limb, Compressible |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.5800 |