The following data is part of a premarket notification filed by Jiangsu Synecoun Medical Technology Co., Ltd. with the FDA for Synecare 1100 Deep Vein Thrombosis Prevention Therapy System.
| Device ID | K211937 |
| 510k Number | K211937 |
| Device Name: | SyneCare 1100 Deep Vein Thrombosis Prevention Therapy System |
| Classification | Sleeve, Limb, Compressible |
| Applicant | Jiangsu Synecoun Medical Technology Co., Ltd. 1/2F East Side,No. 50, G60, Eastside Of Lujia Road, West of Koutai Road, China Medical City Taizhou, CN 225300 |
| Contact | Zhheng Li |
| Correspondent | Ivy Wang Shanghai SUNGO Management Consulting Company Limited. 14th Floor, 1500# Century Avenue Shanghai, CN 200122 |
| Product Code | JOW |
| CFR Regulation Number | 870.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-06-22 |
| Decision Date | 2021-11-18 |