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510(k) K142304

Viberect Penile Vibratory Stimulation Device by Reflexonic, LLC — Product Code KXQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 3, 2014
Date Received
August 18, 2014
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

Other clearances by Reflexonic, LLC

  • K110566 — VIBERECT PENILE VIBRATORY STIMULATION DEVICE (June 24, 2011)

Other clearances for product code KXQ

  • K110566 — VIBERECT PENILE VIBRATORY STIMULATION DEVICE (June 24, 2011)
  • K010096 — MULTI CARE THERAPEUTIC VIBRATOR (March 5, 2001)
  • K955589 — FERTICARE PERSONAL THERAPEUTIC VIBRATOR (April 11, 1996)