Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
Device Classification Under Section 513(f)(2)(De Novo)
FDA Home
Medical Devices
Databases
-
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 Number
890.5670
Classification Product Code
OSD
Date Received
08/20/2010
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
-
-