← Product Code [ITJ](/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/ITJ) · K811485

# WALKER/CRUTCH BAG (K811485)

_Fred Sammons, Inc. · ITJ · Jun 16, 1981 · Physical Medicine · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/ITJ/K811485

## Device Facts

- **Applicant:** Fred Sammons, Inc.
- **Product Code:** [ITJ](/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/ITJ.md)
- **Decision Date:** Jun 16, 1981
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 890.3825
- **Device Class:** Class 1
- **Review Panel:** Physical Medicine

## Regulatory Identification

A mechanical walker is a four-legged device with a metal frame intended for medical purposes to provide moderate weight support while walking. It is used by disabled persons who lack strength, good balance, or endurance.

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**Source:** [https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/ITJ/K811485](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/ITJ/K811485)

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