Device Classification Name |
Stimulator, Nerve, Transcutaneous, Over-The-Counter
More FDA Info for this Device |
510(K) Number |
K200561 |
Device Name |
Stimulator, Nerve, Transcutaneous, Over-The-Counter |
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 |
882.5890
More FDA Info for this Regulation Number |
Classification Product Code |
NUH
Other 510(k) Applications for this Device
More FDA Info for this Product Code |
Date Received |
03/04/2020 |
Decision Date |
07/01/2020 |
Decision |
SESE - SUBST EQUIV |
Classification Advisory Committee |
NE - Neurology |
Review Advisory Committee |
NE - Neurology |
Statement / Summary / Purged Status |
Summary |
Type |
Special |
Reviewed By Third Party |
N |
Expedited Review |
|