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Diathermy is used therapeutically to increase the temperature of tissues. It is generally accepted that heat produces the following desirable therapeutic effects:

• Increases the extensibility of collagen tissues 1.
• 2. Decreases joint stiffness
• 3. Relieves pain
• 4. Relieves muscle spasm
• న. Increases blood flow

The Megapulse Shortwave Diathermy system is indicated for use in the following con-Ditions or applications:

• Disorders of the musculoskeletal system: 1. muscle spasm joint stiffness, contractures ----------
• 2. Chronic inflammatory or infective conditions: tenosynovitis, bursitis, synovitis chronic inflammatory pelvic diseases

MEGAPULSE II is a Shortwave Diathermy system.

This document is a 510(k) clearance letter from the FDA for a device called "Megapulse II, Model 3029." It does not contain any information about acceptance criteria or a study proving the device meets those criteria.

The letter is primarily a notification that the device has been found substantially equivalent to predicate devices already on the market, permitting it to be marketed. It lists the "Indications for Use" for the device, which are the therapeutic effects and conditions it is intended to treat.

Since the document does not contain the requested information, I cannot fill out the table or answer the specific questions about acceptance criteria and study details.

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