Device Classification Name |
Sleeve, Limb, Compressible
More FDA Info for this Device |
510(K) Number |
K202839 |
Device Name |
Sleeve, Limb, Compressible |
Applicant |
JKH HEALTH CO., LTD.
4-5F, Building 12, Hengmingzhu Ind. Park, Tongfuyu Ind.
Area, Shajing, Baoan
Shenzhen 518104 CN
Other 510(k) Applications for this Company
|
Contact |
Pu Jiang
Other 510(k) Applications for this Contact |
Regulation Number |
870.5800
More FDA Info for this Regulation Number |
Classification Product Code |
JOW
Other 510(k) Applications for this Device
More FDA Info for this Product Code |
Date Received |
09/25/2020 |
Decision Date |
01/21/2021 |
Decision |
SESE - SUBST EQUIV |
Classification Advisory Committee |
CV - Cardiovascular |
Review Advisory Committee |
CV - Cardiovascular |
Statement / Summary / Purged Status |
Statement |
Type |
Traditional |
Reviewed By Third Party |
N |
Expedited Review |
|