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FDA 510(k) Application Details - K191151
Device Classification Name
Stimulator, Nerve, Transcutaneous, Over-The-Counter
More FDA Info for this Device
510(K) Number
K191151
Device Name
Stimulator, Nerve, Transcutaneous, Over-The-Counter
Applicant
JKH USA, LLC
1142 S. Diamond Bar Blvd, #861
Diamond Bar, CA 91765 US
Other 510(k) Applications for this Company
Contact
Bill Quanqin Dai
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
05/01/2019
Decision Date
06/21/2019
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
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