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510(k) Data Aggregation
(196 days)
Megapulse III Shortwave Diathermy
Diathermy is used therapeutically to increase the temperature of tissues. It is generally accepted that heat produces the following desirable therapeutic effects:
- · Relieves pain
- · Increases the extensibility of collagen tissues
- · Decreases joint stiffness
- · Relieves muscle spasm
- Increases local blood flow
Megapulse Shortwave Diathermy system is indicated for use in the following conditions or applications:
- · Disorders of the musculoskeletal system
- o Muscle spasm
- o Joint stiffness
- o Joint contractures
- · Chronic inflammatory or infective conditions
- o Tenosynovitis
- o Bursitis
- o Synovitis
- o Chronic inflammatory pelvic diseases
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I am sorry, but the provided text is a 510(k) premarket notification letter from the FDA to a medical device manufacturer, along with the device's indications for use. It primarily focuses on the regulatory approval of the "Megapulse III Shortwave Diathermy" device based on substantial equivalence to existing devices.
This document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert ground truth, or adjudication methods. It does not present data from a study proving the device meets specific performance criteria.
Therefore, I cannot provide the requested table and information as it is not present in the given text.
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