← Product Code [IOB](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IOB) · K842276

# SUNMASTER (K842276)

_Mt. Hood Mfr., Inc. · IOB · Jul 16, 1984 · Physical Medicine · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IOB/K842276

## Device Facts

- **Applicant:** Mt. Hood Mfr., Inc.
- **Product Code:** [IOB](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IOB.md)
- **Decision Date:** Jul 16, 1984
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 890.5500
- **Device Class:** Class 2
- **Review Panel:** Physical Medicine

## Regulatory 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.

## 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.

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**Source:** [https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IOB/K842276](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IOB/K842276)

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