IOA · Diathermy, Microwave, For Use In Applying Therapeutic Deep Heat
Physical Medicine · 21 CFR 890.5275 · Class 2
Overview
| Product Code | IOA |
|---|---|
| Device Name | Diathermy, Microwave, For Use In Applying Therapeutic Deep Heat |
| Regulation | 21 CFR 890.5275 |
| Device Class | Class 2 |
| Review Panel | Physical Medicine |
| 3rd-Party Reviewable | Yes |
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.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (4 of 4)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K941567 | DIATHERMY DEVICE-MICROFOCUS | Cheung Laboratories, Inc. | Apr 22, 1996 | SESE |
| K895000 | NEMECTRON MICROWAVE | Nemectron Medical, Inc. | Jul 27, 1990 | SESE |
| K862029 | SIEMENS RADIOTHERM 706, MICROWAVE THERAPY UNIT | Elmed, Inc. | Jul 16, 1986 | SESE |
| K860082 | THERMOTRON 918 | Medical Microwave Research Corp. | Mar 27, 1986 | SESE |
Top Applicants
- Cheung Laboratories, Inc. — 1 clearance
- Elmed, Inc. — 1 clearance
- Medical Microwave Research Corp. — 1 clearance
- Nemectron Medical, Inc. — 1 clearance
