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The GS-128 Gradient Compression System is a sequential gradient compression pneumatic device used for the treatment and management of venous or lymphatic disorder of the limbs.

Indications For Use:

Common Indications Peripheral edema Lymphedema (Postmastectomy, congenital) Venous Stasis Ulcers Venous Insufficiency Stump reduction Hand edema

The GS-128 Gradient Compression System is a sequential gradient compression pneumatic device used for the treatment and management of venous or lymphatic disorder of the limbs.

This document is a 510(k) premarket notification decision letter for a medical device, the MedMark Technologies, LLC Model GS-128 Sequential Compression System. It confirms that the FDA has found the device to be substantially equivalent to legally marketed predicate devices.

The document provided does not contain information regarding acceptance criteria, device performance results, or details of any studies conducted. It is a regulatory clearance letter, not a study report. Therefore, I cannot extract the requested information points from this input.

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