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FDA 510(k) Application Details - K082057
Device Classification Name
Stimulator, Nerve, Transcutaneous, For Pain Relief
More FDA Info for this Device
510(K) Number
K082057
Device Name
Stimulator, Nerve, Transcutaneous, For Pain Relief
Applicant
SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.
FANSHENXUSHENG INDUSTRIAL
ESTATE
SHENZHEN, BAO'AN DISTRICT 518108 CN
Other 510(k) Applications for this Company
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
07/21/2008
Decision Date
02/26/2009
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
Y
Expedited Review
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