← Product Code [IPR](/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/IPR) · K821403

# LIGHT WEIGHT ALUMINUM CRUTCHES (K821403)

_Manuco Manufacturing Co., Inc. · IPR · Jun 21, 1982 · Physical Medicine · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/IPR/K821403

## Device Facts

- **Applicant:** Manuco Manufacturing Co., Inc.
- **Product Code:** [IPR](/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/IPR.md)
- **Decision Date:** Jun 21, 1982
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 890.3150
- **Device Class:** Class 1
- **Review Panel:** Physical Medicine

## Regulatory Identification

A crutch is a device intended for medical purposes for use by disabled persons to provide minimal to moderate weight support while walking.

---

**Source:** [https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/IPR/K821403](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/IPR/K821403)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com