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FDA 510(k) Application Details - K133929
Device Classification Name
Stimulator, Nerve, Transcutaneous, Over-The-Counter
More FDA Info for this Device
510(K) Number
K133929
Device Name
Stimulator, Nerve, Transcutaneous, Over-The-Counter
Applicant
SHENZHEN OSTO TECHNOLOGY COMPANY LIMITED
N0. 43 LONGFENG ROAD
XINSHENG COMMUNITY, LONGGANG STREET, LONGGANG DISTRICT
SHENZHEN CITY, GUANGDONG PROVINCE 518116 CN
Other 510(k) Applications for this Company
Contact
LI YANG
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
12/23/2013
Decision Date
11/12/2014
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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