510(k) DEN100023
DEN100023 is an FDA 510(k) premarket notification submitted by National Center For Pelvic Pain Research Devices, for the device "AHIP INTERNAL TRIGGER POINT WAND MODEL: 1". The FDA issued a decision of De Novo Granted on November 20, 2012. The device falls under product code OSD (Massager, Therapeutic, To Internally Massage Trigger Points In The Pelvic Floor Musculature), a Class II device regulated under 21 CFR 890.5670.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- November 20, 2012
- Date Received
- August 20, 2010
- Clearance Type
- Post-NSE
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Massager, Therapeutic, To Internally Massage Trigger Points In The Pelvic Floor Musculature
- Device Class
- Class II
- Regulation Number
- 890.5670
- Review Panel
- PM
- Submission Type
Rectal or vaginal use manual therapeutic massager device to massage irritable, sore trigger points (trps) in the pelvic floor musculature in order to reduce internal pelvic floor trigger point sensitivity