← Product Code [IOA](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IOA) · K941567

# DIATHERMY DEVICE-MICROFOCUS (K941567)

_Cheung Laboratories, Inc. · IOA · Apr 22, 1996 · Physical Medicine · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IOA/K941567

## Device Facts

- **Applicant:** Cheung Laboratories, Inc.
- **Product Code:** [IOA](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IOA.md)
- **Decision Date:** Apr 22, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 890.5275
- **Device Class:** Class 2
- **Review Panel:** Physical Medicine

## Regulatory Identification

A microwave diathermy for use in applying therapeutic deep heat for selected medical conditions is a device that applies to specific areas of the body electromagnetic energy in the microwave frequency bands of 915 megahertz to 2,450 megahertz 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.

---

**Source:** [https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IOA/K941567](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IOA/K941567)

**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
