21 CFR 890.5300 — Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat
Physical Medicine (PM) · Part 890 Subpart F—Physical Medicine Therapeutic Devices · § 890.5300
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).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| IMI | Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat | 2 | 89 | 3rd Party |
| LXF | Diathermy, Ultrasonic, For Use Other Than Applying Therapeutic Deep Heat | 3 | 0 | |
| PFW | Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat | 2 | 8 | 3rd Party |
