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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, for pain relief
510(k) Number K121184
Model SE-001
Device Name SENSUS
Original Applicant
62 fourth ave.
waltham,  MA  02451
Original Contact rainer maas
Regulation Number882.5890
Classification Product Code
Date Received04/18/2012
Decision Date 08/02/2012
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