IPO · Orthosis, Pneumatic Structure, Rigid
Physical Medicine · 21 CFR 890.3610 · Class 3
Overview
| Product Code | IPO |
|---|---|
| Device Name | Orthosis, Pneumatic Structure, Rigid |
| Regulation | 21 CFR 890.3610 |
| Device Class | Class 3 |
| Review Panel | Physical Medicine |
Identification
A rigid pneumatic structure orthosis is a device intended for medical purposes to provide whole body support by means of a pressurized suit to help thoracic paraplegics walk.
Classification Rationale
Class III (premarket approval).
Recent Cleared Devices (0 of 0)
No cleared devices on record.
