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Ultrasonic Therapy Product or Ultrasonic Diathermy
Ultrasonic therapy or ultrasonic diathermy products used in physical therapy equipment produce high-frequency sound waves that travel deep into tissue and create gentle therapeutic heat. Ultrasonic diathermy is intended to generate deep heat within body tissues for the treatment of selected medical conditions such as pain, muscle spasms and joint contractures, but not for the treatment of malignancies. The sound waves are transmitted through a round-headed wand that the therapist applies to the skin with gentle, circular movements. A hypo-allergenic gel aids in the transmission of the ultrasonic energy and prevents overheating at the surface of the applicator. Treatments usually last between five and 10 minutes. Ultrasonic therapy does not hurt (there may be a bit of a tingling sensation and/or a sensation of warmth) if the therapist keeps the wand moving continuously. If, however, the wand is held in place for more than a few seconds, it can become uncomfortable at higher energies. While ultrasonic therapy can be used to treat the conditions described above, it is important to know that there are situations and areas of the body where it cannot safely be used. You should notify the practitioner administering the ultrasound if any of the following applies to you:
You should also be aware that commercial ultrasonic diathermy devices may exist that have not been formally evaluated by FDA. Typically, these devices will claim to treat a range of diseases, disorders, and have other uses that are not covered in the description above (for example, to reduce wrinkles on the face). If you have questions as to whether FDA has evaluated a certain device for a particular use or not, please contact the Division of Small Manufacturer, International and Consumer Assistance ( DSMICA, email: dsma@cdrh.fda.gov). Over the years, FDA has evaluated a number of ultrasonic diathermy devices. They are all capable of heating deep tissue to a therapeutic temperature range of 40-45°C for the selected conditions described above. However, there are various configurations with regard to energy output and applicator size. Furthermore, there may be instructions that apply only to a particular device. Therefore, it is important that you read and be familiar with the instructions for the particular device that you use. You should also be especially mindful of all contraindications, warnings, and precautions that apply to the device. Laws, Regulations, & Standards Manufacturers of electronic radiation emitting products sold in the United States are responsible for compliance with the Federal Food, Drug and Cosmetic Act (FFDCA), Chapter V, Subchapter C - Electronic Product Radiation Control. Manufacturers of ultrasonic therapy products are responsible for compliance with all applicable requirements of Title 21 Code of Federal Regulations (Subchapter J, Radiological Health) Parts 1000 through 1005: 1003 - Notification of defects or failure to comply 1004 - Repurchase, repairs, or replacement of electronic products 1005 - Importation of electronic products In addition, ultrasonic therapy devices must comply with radiation safety performance standards in Title 21 Code of Federal Regulations (Subchapter J, Radiological Health) Parts 1010 and 1050.10: 1010 - Performance standards for electronic products: general Because they are medical devices, ultrasonic therapy products must also comply with the medical device regulations. For more information, see Getting to Market with a Medical Device. The FDA regulates radiation emitting products. The CDRH provides Device Advice to help manufacturers and distributors of these products comply with the provisions of the Federal Food, Drug and Cosmetic Act. The CDRH provides guidance to ultrasonic therapy manufacturers in the form of notices, and useful webpage links. Here are some useful links and documents in Portable Document Format (PDF) that are viewable with Adobe Reader:
Reporting Forms The CDRH provides reporting forms to ultrasonic therapy manufacturers to assist them with preparation of product and other reports or submissions. Here are links to the CeSub Electronic Submissions software and paper reporting forms in Adobe Portable Document Format (PDF) that are viewable with Adobe Reader: Reporting Guide: Guide for Preparing Product Reports for Ultrasonic Therapy Products Reporting Guide: Annual Report CeSub Electronic Report Submissions Software Updated March 17, 2009 |
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