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 890.5300](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/890.5300) → LXF — Diathermy, Ultrasonic, For Use Other Than Applying Therapeutic Deep Heat

# LXF · Diathermy, Ultrasonic, For Use Other Than Applying Therapeutic Deep Heat

_Physical Medicine · 21 CFR 890.5300 · Class 3_

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

## Overview

- **Product Code:** LXF
- **Device Name:** Diathermy, Ultrasonic, For Use Other Than Applying Therapeutic Deep Heat
- **Regulation:** [21 CFR 890.5300](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/890.5300)
- **Device Class:** 3
- **Review Panel:** [Physical Medicine](/submissions/PM)

## Identification

An ultrasonic diathermy for use in applying therapeutic deep heat for selected medical conditions is a device that applies to specific areas of the body ultrasonic energy at a frequency beyond 20 kilohertz and that is intended to generate deep heat within body tissues for the treatment of selected medical conditions such as relief of pain, muscle spasms, and joint contractures, but not for the treatment of malignancies.

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (0 of 0)

_No cleared devices on record._

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

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