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FDA 510(k) Application Details - K162718
Device Classification Name
Stimulator, Neuromuscular, External Functional
More FDA Info for this Device
510(K) Number
K162718
Device Name
Stimulator, Neuromuscular, External Functional
Applicant
SHENZHEN XFT Medical Limited
RM 203, BLD1, 14JINHUI ROAD, NEW DISTRICT
SHENZHEN CN
Other 510(k) Applications for this Company
Contact
JIANG XIAOYING
Other 510(k) Applications for this Contact
Regulation Number
882.5810
More FDA Info for this Regulation Number
Classification Product Code
GZI
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/29/2016
Decision Date
11/30/2017
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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