Device Classification Name |
sleeve, limb, compressible
|
510(k) Number |
K211937 |
Device Name |
SyneCare 1100 Deep Vein Thrombosis Prevention Therapy System |
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
|
|
Applicant Contact |
Zhheng Li |
Correspondent |
Shanghai SUNGO Management Consulting Company Limited. |
14th Floor, 1500# Century Avenue |
Shanghai,
CN
200122
|
|
Correspondent Contact |
Ivy Wang |
Regulation Number | 870.5800
|
Classification Product Code |
|
Date Received | 06/22/2021 |
Decision Date | 11/18/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|