Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
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
Reclassification Order Reclassification Order
FDA Review Decision Summary
Type Post-NSE
-
-