Browse hierarchy: [Physical Medicine (PM)](/submissions/PM) → [Subpart F — Physical Medicine Therapeutic Devices](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices) → [21 CFR 890.5575](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/890.5575) → IRN — Device, Warning, Overload, External Limb, Powered

# IRN · Device, Warning, Overload, External Limb, Powered

_Physical Medicine · 21 CFR 890.5575 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IRN

## Overview

- **Product Code:** IRN
- **Device Name:** Device, Warning, Overload, External Limb, Powered
- **Regulation:** [21 CFR 890.5575](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/890.5575)
- **Device Class:** 2
- **Review Panel:** [Physical Medicine](/submissions/PM)

## Identification

A powered external limb overload warning device is a device intended for medical purposes to warn a patient of an overload or an underload in the amount of pressure placed on a leg.

## Classification Rationale

Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.

## Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.

## Recent Cleared Devices (11 of 11)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K060150](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IRN/K060150.md) | SMARTSTEP SYSTEM/SMARSTEP CLINIC SYSTEM | Andante Medical Devices , Ltd. | Feb 23, 2006 | SESE |
| [K023161](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IRN/K023161.md) | SMARTSTEP SYSTEM | Andante Medical Device, Ltd. | Dec 10, 2002 | SESE |
| [K991313](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IRN/K991313.md) | ACCUTRED SHOE | Orthopedic Technology Research, Inc. | Jun 23, 1999 | SESE |
| [K962591](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IRN/K962591.md) | FOOT WEIGHT ALARM | Cleveland Medical Devices, Inc. | Dec 4, 1996 | SESE |
| [K960307](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IRN/K960307.md) | INDEX SHOE | Orthopedic Technology Research, Inc. | Jun 27, 1996 | SESE |
| [K955034](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IRN/K955034.md) | FORCEGUARD | Impact Monitors, Inc. | Apr 10, 1996 | SESE |
| [K950656](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IRN/K950656.md) | PED ALERT | Orbitec Technologies Corp. | Oct 25, 1995 | SESE |
| [K931517](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IRN/K931517.md) | SAFE-STEP | Lenjoy Engineering, Inc. | Mar 10, 1995 | SESE |
| [K882974](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IRN/K882974.md) | FORCE GUARD I | Boulder Impact Monitors, Inc. | Nov 4, 1988 | SESE |
| [K792241](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IRN/K792241.md) | PELIMIT | Colmed, Ltd. | Nov 30, 1979 | SESE |
| [K770405](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IRN/K770405.md) | OVERLOAD WARNING DEVICE | Synthes (Usa) | Mar 10, 1977 | SESE |

## Top Applicants

- Orthopedic Technology Research, Inc. — 2 clearances
- Andante Medical Device, Ltd. — 1 clearance
- Andante Medical Devices , Ltd. — 1 clearance
- Boulder Impact Monitors, Inc. — 1 clearance
- Cleveland Medical Devices, Inc. — 1 clearance

---

**Source:** [https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IRN](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IRN)

**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