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The SU-100 generates 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.

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This document is a 510(k) premarket notification decision letter from the FDA to SUN-RAIN System Corporation for their SUN-RAIN Ultrasonic Therapy Model SU-100. It states that the device is substantially equivalent to legally marketed predicate devices.

This document DOES NOT contain information regarding acceptance criteria, device performance, sample sizes for testing or training, ground truth establishment, expert qualifications, or details of efficacy studies (such as MRMC or standalone performance).

The letter is a regulatory approval document based on the device's substantial equivalence to existing devices, not a study report detailing performance metrics against specific acceptance criteria.

The information provided only includes:

• Trade Name: SUN-RAIN Ultrasonic Therapy Model SU-100
• Regulation Number: 21 CFR 890.5300
• Regulation Name: Ultrasonic Diathermy
• Regulatory Class: Class II
• Product Code: IMI
• Indications for Use: The SU-100 generates 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.

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