← Product Code [NJB](/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/NJB) · K003128

# MODIFICATION TO RELIEF BRIEF (K003128)

_The JM Kohn Co. · NJB · Aug 12, 2002 · Physical Medicine · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/NJB/K003128

## Device Facts

- **Applicant:** The JM Kohn Co.
- **Product Code:** [NJB](/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/NJB.md)
- **Decision Date:** Aug 12, 2002
- **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/NJB/K003128](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/NJB/K003128)

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