510(k) K110566
K110566 is an FDA 510(k) premarket notification submitted by Reflexonic, LLC for the device "VIBERECT PENILE VIBRATORY STIMULATION DEVICE". The FDA issued a decision of Substantially Equivalent on June 24, 2011. The device falls under product code KXQ (Vibrator For Therapeutic Use, Genital), a Class II device regulated under 21 CFR 884.5960. Reflexonic, LLC has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 24, 2011
- Date Received
- February 28, 2011
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Vibrator For Therapeutic Use, Genital
- Device Class
- Class II
- Regulation Number
- 884.5960
- Review Panel
- OB
- Submission Type