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For Ultrasound

Application of therapeutic deep heat for the treatment of selected sub-chronic and chronic medical conditions such as:

1. Relief of pain, muscle spasms and joint contractures

2. Relief of pain, muscle spasms and joint contractures that may be associated with:

a) Adhesive capsulitis

b) Bursitis with slight calcification

c) Myositis

d) Soft tissue injuries

e) Shortened tendons due to past injuries and scar tissues

3. Relief of sub-chronic and chronic pain and joint contractures resulting from:

a) Capsular tightness

b) Capsular scarring

Not Found

This document is a 510(k) clearance letter from the FDA for a medical device called the "Vectra (Intelect) Genisys Ultrasound." It outlines the device's classification, intended use, and confirms its substantial equivalence to previously marketed devices. However, it does not contain information about acceptance criteria or a study that proves the device meets such criteria.

The information requested in the prompt, such as acceptance criteria, reported device performance, sample sizes, expert qualifications, and ground truth establishment, is typically found in premarket submission documents (like the 510(k) itself or associated test reports), not in the FDA's clearance letter. The clearance letter only states that the FDA reviewed the submission and found the device substantially equivalent based on the information provided by the manufacturer.

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