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FDA 510(k) Application Details - K171978
Device Classification Name
Stimulator, Muscle, Powered
More FDA Info for this Device
510(K) Number
K171978
Device Name
Stimulator, Muscle, Powered
Applicant
Shenzhen Dongdixin Technology Co., Ltd.
No. 3 Building Xilibaimang Xusheng Industrial Estate
Nanshan
Shenzhen 518108 CN
Other 510(k) Applications for this Company
Contact
Siping Yuan
Other 510(k) Applications for this Contact
Regulation Number
890.5850
More FDA Info for this Regulation Number
Classification Product Code
IPF
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/30/2017
Decision Date
10/02/2017
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
PM - Physical Medicine
Review Advisory Committee
PM - Physical Medicine
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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