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 890.5760](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/890.5760) → OTX — Foot Wrap For Treating Restless Leg Syndrome Symptoms

# OTX · Foot Wrap For Treating Restless Leg Syndrome Symptoms

_Physical Medicine · 21 CFR 890.5760 · Class 1_

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

## Overview

- **Product Code:** OTX
- **Device Name:** Foot Wrap For Treating Restless Leg Syndrome Symptoms
- **Regulation:** [21 CFR 890.5760](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/890.5760)
- **Device Class:** 1
- **Review Panel:** [Physical Medicine](/submissions/PM)

## Identification

A nonpowered lower extremity pressure wrap is a prescription device that applies mechanical pressure by wrapping around the lower extremity, such as the leg or foot, and is intended for primary Restless Leg Syndrome.

## Classification Rationale

Class I (general 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 (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [DEN110009](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/OTX/DEN110009.md) | RESTLESS LEG DEVICE | Mary M. Sorg (An Individual) Dba PJ Sleeper'S | Dec 18, 2013 | DENG |

## Top Applicants

- Mary M. Sorg (An Individual) Dba PJ Sleeper'S — 1 clearance

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

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