DIATHERMY DEVICE-MICROFOCUS
Device Facts
| Record ID | K941567 |
|---|---|
| Device Name | DIATHERMY DEVICE-MICROFOCUS |
| Applicant | Cheung Laboratories, Inc. |
| Product Code | IOA · Physical Medicine |
| Decision Date | Apr 22, 1996 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 890.5275 |
| Device Class | Class 2 |
Regulatory Classification
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.
