FDA 510(k) Application Details - K202839

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