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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
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Device Classification Name computerized behavioral therapy device for migraine
De Novo Number DEN240064
Device Name CT-132
Requester
click therapeutics, inc.
80 white st
3rd floor
new york,  NY  10013
Contact dr. shaheen lakhan
Regulation Number882.5806
Classification Product Code
SEE  
Date Received11/12/2024
Decision Date 04/11/2025
Decision granted (DENG)
Classification Advisory Committee Neurology
Review Advisory Committee Neurology
Classification Order Classification Order
Type Direct
Predetermined Change
Control Plan Authorized		 No
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