FDA product code IPO: Orthosis, Pneumatic Structure, Rigid
IPO is the FDA product code for orthosis, pneumatic structure, rigid. It is a Class III device, regulated under 21 CFR 890.3610 and reviewed by the Physical Medicine panel. Devices under IPO reach the market by PMA; FDA lists no cleared 510(k)s for it.
Definition
Call for PMAs to be filed by 12/26/96 per 61 FR 50711 on 9/27/96
Classification
| Field | Value |
|---|---|
| Device name | Orthosis, Pneumatic Structure, Rigid |
| Device class | Class III |
| Regulation | 21 CFR 890.3610 |
| Review panel | PM — Physical Medicine |
| Medical specialty | Physical Medicine |
| Premarket route | PMA |
Recalls for IPO devices
openFDA lists no recalls for product code IPO.
Frequently asked questions
What is FDA product code IPO?
IPO is the FDA product code for orthosis, pneumatic structure, rigid. It is a Class III device, regulated under 21 CFR 890.3610 and reviewed by the Physical Medicine panel.
What device class is IPO?
Class III, regulation 21 CFR 890.3610. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code IPO
- Run a recall and safety report across every IPO manufacturer
- Watch product code IPO 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.
All Physical Medicine product codes · FDA product code lookup