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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 K120500
Models 11.1510, 11.3000
Device Name THE PAIN PILOT (A.K.A PAIN PILOT)
Original Applicant
HOLLYWOG, LLC
2830 amnicola hwy
chattanooga,  TN  37406
Original Contact michael w treas
Regulation Number882.5890
Classification Product Code
NUH  
Date Received02/21/2012
Decision Date 08/20/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Neurology
Review Advisory Committee Neurology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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