Browse hierarchy: [Physical Medicine (PM)](/submissions/PM) → [Subpart D — Physical Medicine Prosthetic Devices](/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices) → [21 CFR 890.3610](/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/890.3610) → IPO — Orthosis, Pneumatic Structure, Rigid

# IPO · Orthosis, Pneumatic Structure, Rigid

_Physical Medicine · 21 CFR 890.3610 · Class 3_

**Canonical URL:** https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/IPO

## Overview

- **Product Code:** IPO
- **Device Name:** Orthosis, Pneumatic Structure, Rigid
- **Regulation:** [21 CFR 890.3610](/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/890.3610)
- **Device Class:** 3
- **Review Panel:** [Physical Medicine](/submissions/PM)

## 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._

---

**Source:** [https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/IPO](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/IPO)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com