FDA 510(k) Application Details - K113724

Device Classification Name Stimulator, Transcutaneous Electrical, Aesthetic Purposes

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510(K) Number K113724
Device Name Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Applicant PAIN RELIEF TECHNOLOGIES
15048 SW CAPSTONE CT.
BEAVERTON, OR 97007 US
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Contact KENDALL GORHAM
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Regulation Number 882.5890

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Classification Product Code NFO
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Date Received 12/19/2011
Decision Date 02/15/2012
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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