LXF · Diathermy, Ultrasonic, For Use Other Than Applying Therapeutic Deep Heat
Physical Medicine · 21 CFR 890.5300 · Class 3
Overview
| Product Code | LXF |
|---|---|
| Device Name | Diathermy, Ultrasonic, For Use Other Than Applying Therapeutic Deep Heat |
| Regulation | 21 CFR 890.5300 |
| Device Class | Class 3 |
| Review Panel | Physical Medicine |
Identification
An ultrasonic diathermy for use in applying therapeutic deep heat for selected medical conditions is a device that applies to specific areas of the body ultrasonic energy at a frequency beyond 20 kilohertz 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 (0 of 0)
No cleared devices on record.
