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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 massager, therapeutic, to internally massage trigger points in the pelvic floor musculature
De Novo Number DEN100023
510(K) Number K100934
Device Name AHIP INTERNAL TRIGGER POINT WAND MODEL: 1
Requester
national center for pelvic pain research devices,
12470 fiori lane
sebastopol,  CA  95472
Contact david wise
Regulation Number890.5670
Classification Product Code
OSD  
Date Received08/20/2010
Decision Date 11/20/2012
Decision granted (DENG)
Classification Advisory Committee Physical Medicine
Review Advisory Committee Physical Medicine
Classification Order Classification Order
FDA Review Decision Summary
Type Post-NSE
Predetermined Change
Control Plan Authorized		 No
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