HII — Stimulator, Vaginal, Muscle, Powered, For Therapeutic Use Class III

FDA Device Classification

FDA product code HII covers "Stimulator, Vaginal, Muscle, Powered, For Therapeutic Use", a Class III medical device regulated under 21 CFR 884.5940. Submissions are reviewed by the Obstetrics/Gynecology panel.

Classification Details

Product Code
HII
Device Class
Class III
Regulation Number
884.5940
Submission Type
Review Panel
OB
Medical Specialty
Obstetrics/Gynecology
Implant
No

Definition

Call for PMAs to be filed by 7/12/2000 per 65 FR 19834 on 4/13/00