← Product Code [ILH](/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/ILH) · K812349

# HAND SPLINTS & COMPONENTS (K812349)

_Fred Sammons, Inc. · ILH · Sep 11, 1981 · Physical Medicine · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/ILH/K812349

## Device Facts

- **Applicant:** Fred Sammons, Inc.
- **Product Code:** [ILH](/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/ILH.md)
- **Decision Date:** Sep 11, 1981
- **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/ILH/K812349](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/ILH/K812349)

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