Device Classification Name |
sleeve, limb, compressible
|
510(k) Number |
K202839 |
Device Name |
Overlapped Compression Therapy |
Applicant |
JKH HEALTH CO., LTD. |
4-5F, Building 12, Hengmingzhu Ind. Park, Tongfuyu Ind. |
Area, Shajing, Baoan |
Shenzhen,
CN
518104
|
|
Applicant Contact |
Pu Jiang |
Correspondent |
JKH HEALTH CO., LTD. |
4-5F, Building 12, Hengmingzhu Ind. Park, Tongfuyu Ind. |
Area, Shajing, Baoan |
Shenzhen,
CN
518104
|
|
Correspondent Contact |
Pu Jiang |
Regulation Number | 870.5800
|
Classification Product Code |
|
Date Received | 09/25/2020 |
Decision Date | 01/21/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|