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FDA 510(k) Application Details - K181645
Device Classification Name
Stimulator, Nerve, Transcutaneous, For Pain Relief
More FDA Info for this Device
510(K) Number
K181645
Device Name
Stimulator, Nerve, Transcutaneous, For Pain Relief
Applicant
Pierenkemper GmbH
Am Geiersberg 6
Ehringshausen 35630 DE
Other 510(k) Applications for this Company
Contact
Thorsten Reichel
Other 510(k) Applications for this Contact
Regulation Number
882.5890
More FDA Info for this Regulation Number
Classification Product Code
GZJ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/22/2018
Decision Date
08/13/2020
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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