← Product Code [IQI](/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/IQI) · K823812

# VARIOUS SUPPORTS AND SPLINTS (K823812)

_Danek Medical, Inc. · IQI · Jan 14, 1983 · Physical Medicine · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/IQI/K823812

## Device Facts

- **Applicant:** Danek Medical, Inc.
- **Product Code:** [IQI](/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/IQI.md)
- **Decision Date:** Jan 14, 1983
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 890.3475
- **Device Class:** Class 1
- **Review Panel:** Physical Medicine

## Regulatory Identification

A limb orthosis (brace) is a device intended for medical purposes that is worn on the upper or lower extremities to support, to correct, or to prevent deformities or to align body structures for functional improvement. Examples of limb orthoses include the following: A whole limb and joint brace, a hand splint, an elastic stocking, a knee cage, and a corrective shoe.

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**Source:** [https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/IQI/K823812](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/IQI/K823812)

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