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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name stimulator, nerve, transcutaneous, over-the-counter
510(k) Number K132563
Device Name PINOOK STIMULATOR
Applicant
PINOOK USA
5703 OBERLIN DRIVE STE 306
SAN DIEGO,  CA  92121
Applicant Contact TEJAS SHAH
Correspondent
PINOOK USA
5703 OBERLIN DRIVE STE 306
SAN DIEGO,  CA  92121
Correspondent Contact TEJAS SHAH
Regulation Number882.5890
Classification Product Code
NUH  
Subsequent Product Code
NGX  
Date Received08/15/2013
Decision Date 04/24/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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