FDA 510(k) Application Details - K240011

Device Classification Name	Sleeve, Limb, Compressible   More FDA Info for this Device
510(K) Number	K240011
Device Name	Sleeve, Limb, Compressible
Applicant	JKH Health Co., Ltd. 4-5F, Building 12, Hengmingzhu Industrial Park, Xinqiao Tongfuyu Industrial 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	01/02/2024
Decision Date	02/23/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review