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FDA 510(k) Application Details - K170659
Device Classification Name
Stimulator, Nerve, Transcutaneous, Over-The-Counter
More FDA Info for this Device
510(K) Number
K170659
Device Name
Stimulator, Nerve, Transcutaneous, Over-The-Counter
Applicant
IQ Technologies Inc.
6672 Spencer St., Ste 800
Las Vegas, NV 89119 US
Other 510(k) Applications for this Company
Contact
Elli Josef
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
03/03/2017
Decision Date
05/26/2017
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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