Device Classification Name massager, therapeutic, to internally massage trigger points in the pelvic floor musculature
510(k) Number K100934
Model 1
Device Name AHIP INTERNAL TRIGGER POINT WAND MODEL: 1
Original Applicant
NATIONAL CENTER FOR PELVIC PAIN RESEARCH DEVICES,
12470 fiori lane
sebastopol,  CA  95472
Original Contact david wise
Regulation Number890.5670
Classification Product Code
OSD  
Date Received04/05/2010
Decision Date 11/20/2012
Decision de novo petitions granted (AN)
Classification Advisory Committee Physical Medicine
Review Advisory Committee Neurology
FOI Item Approval Letter
FDA Review Decision Summary
Type De Novo Petitions Granted
Clinical Trials NCT01097824
Reviewed by Third Party No
Expedited Review No
Combination Product No