← Product Code [ITO](/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/ITO) · K800716

# ORTHOTIC LEG GAIT CORRECTOR DEVICE (K800716)

_Ipos Luneburg · ITO · May 2, 1980 · Physical Medicine · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/ITO/K800716

## Device Facts

- **Applicant:** Ipos Luneburg
- **Product Code:** [ITO](/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/ITO.md)
- **Decision Date:** May 2, 1980
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 890.3410
- **Device Class:** Class 1
- **Review Panel:** Physical Medicine

## Regulatory Identification

An external limb orthotic component is a device intended for medical purposes for use in conjunction with an orthosis (brace) to increase the function of the orthosis for a patient's particular needs. Examples of external limb orthotic components include the following: A brace-setting twister and an external brace stirrup.

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**Source:** [https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/ITO/K800716](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/ITO/K800716)

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