FDA product code HII: Stimulator, Vaginal, Muscle, Powered, For Therapeutic Use
HII is the FDA product code for stimulator, vaginal, muscle, powered, for therapeutic use. It is a Class III device, regulated under 21 CFR 884.5940 and reviewed by the Obstetrics and Gynecology panel. Devices under HII reach the market by PMA; FDA lists no cleared 510(k)s for it.
Definition
Call for PMAs to be filed by 7/12/2000 per 65 FR 19834 on 4/13/00
Classification
| Field | Value |
|---|---|
| Device name | Stimulator, Vaginal, Muscle, Powered, For Therapeutic Use |
| Device class | Class III |
| Regulation | 21 CFR 884.5940 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | PMA |
Recalls for HII devices
openFDA lists no recalls for product code HII.
Frequently asked questions
What is FDA product code HII?
HII is the FDA product code for stimulator, vaginal, muscle, powered, for therapeutic use. It is a Class III device, regulated under 21 CFR 884.5940 and reviewed by the Obstetrics and Gynecology panel.
What device class is HII?
Class III, regulation 21 CFR 884.5940. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code HII
- Run a recall and safety report across every HII manufacturer
- Watch product code HII for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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