The following data is part of a premarket notification filed by Jiangsu Synecoun Medical Technology Co., Ltd. with the FDA for Synecare 1000 Deep Vein Thrombosis Prevention Therapy System.
| Device ID | K203310 |
| 510k Number | K203310 |
| Device Name: | SyneCare 1000 Deep Vein Thrombosis Prevention Therapy System |
| Classification | Sleeve, Limb, Compressible |
| Applicant | Jiangsu Synecoun Medical Technology Co., Ltd. East Of 1/F. No. 50, G60, Eastside Of Lujia Road, Westside of Koutai Road. CMC Taizhou, CN 225316 |
| Contact | Yue Li |
| Correspondent | Yue Li Jiangsu Synecoun Medical Technology Co., Ltd. East Of 1/F. No. 50, G60, Eastside Of Lujia Road, Westside of Koutai Road. CMC Taizhou, CN 225316 |
| Product Code | JOW |
| CFR Regulation Number | 870.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-11-10 |
| Decision Date | 2021-04-02 |