← Product Code [IPX](/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/IPX) · K823662

# RIB BELT (UNIVERSAL) (K823662)

_Warm & Form, Orthopedic Materials · IPX · Dec 30, 1982 · Physical Medicine · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/IPX/K823662

## Device Facts

- **Applicant:** Warm & Form, Orthopedic Materials
- **Product Code:** [IPX](/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/IPX.md)
- **Decision Date:** Dec 30, 1982
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 890.3490
- **Device Class:** Class 1
- **Review Panel:** Physical Medicine

## Regulatory Identification

A truncal orthosis is a device intended for medical purposes to support or to immobilize fractures, strains, or sprains of the neck or trunk of the body. Examples of truncal orthoses are the following: Abdominal, cervical, cervical-thoracic, lumbar, lumbo-sacral, rib fracture, sacroiliac, and thoracic orthoses and clavicle splints.

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**Source:** [https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/IPX/K823662](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/IPX/K823662)

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