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 890.5500](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/890.5500) → LBG — Device, Fluidized Therapy, Dry Heat

# LBG · Device, Fluidized Therapy, Dry Heat

_Physical Medicine · 21 CFR 890.5500 · Class 2_

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

## Overview

- **Product Code:** LBG
- **Device Name:** Device, Fluidized Therapy, Dry Heat
- **Regulation:** [21 CFR 890.5500](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/890.5500)
- **Device Class:** 2
- **Review Panel:** [Physical Medicine](/submissions/PM)
- **3rd-party reviewable:** yes

## Identification

An infrared lamp is a device intended for medical purposes that emits energy at infrared frequencies (approximately 700 nanometers to 50,000 nanometers) to provide topical heating.

## Classification Rationale

Class II (special controls). The device, when it is an infrared therapeutic heating lamp, 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, when it is an infrared therapeutic heating lamp, 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 |
| --- | --- | --- | --- | --- |
| [K834293](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/LBG/K834293.md) | ELECTRONIC CELL ENERGIZER | Electronic Energy, Inc. | Jan 13, 1984 | SESE |

## Top Applicants

- Electronic Energy, Inc. — 1 clearance

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

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