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510(k) Data Aggregation
(214 days)
VECTRA COMBO
For Ultrasound: Ultrasound for use in applying deep heat can be used for treatment of selected medical Childious such as the relief of pain, muscle spasms and joint contractures. These conditions may be associated with adhesive capsulitis, bursitis with slight calcification, myositis and soft tissue injuries. Ultrasound can provide therapeutic deep heating between 40° and 45°C.
For VMS, Russian, Monophasic Hi-Volt:
- Relaxation of muscle spasms
- Prevention or retardation of disuse atrophy
- Increasing local blood circulation 1
- Muscle re-education
- Maintaining or increasing range of motion
- Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis
For Microcurrent, Interferential and Premodulated:
- = Symptomatic relief of chronic, intractable pain
- Management of pain associated with post-traumatic or post-operative conditions
Not Found
I am sorry but I am unable to answer your request. The document provided does not contain information about acceptance criteria, device performance, sample sizes, or study details. It is a letter from the FDA regarding 510(k) premarket notification for several medical devices, confirming their substantial equivalence to previously marketed devices and outlining regulatory requirements.
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