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Reduction of Secondary Lymphedema of the Arm (SLA) Post Mastectomy Improvement of Secondary Lymphedema Improvement of lymphatic circulation in the treated area

The Cellu M6 Keymodule i electrical therapeutic massager is comprised of a program console housing a vacuum pump and a regulation system. The main treatment head 150 consists of two parallel motorized rollers housed in a chamber which produces both negative pressure above the rollers and positive pressure below the rollers. This technology creates a skin fold between the two rollers in a suction chamber. thus mimicking the "rolled palpation" of manual massage techniques. In addition to Head i50 which is meant primarily for the upper arm and for legs, auxiliary heads T615, T615-A, T630, T630-A, T644 and T644-A are also used, as they better suit smaller morphology (parts) of the body. Details are provided along the labeling provided. This device has the capability to produce both constant and sequential aspiration. Constant aspiration provides a deeper massage, which also mobilizes the muscle fascia. With sequential aspiration, the suction power is cyclically interrupted to provide pulsation to the skin fold between the two rollers and a softer, gentler stroking action of the tissues. The suction power ranges from 45 mm Hg to 180 mmHg, which is represented by a power level scale ranging from 1 to 4.

The provided text does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.

The document is a 510(k) summary for the "Cellu M6 Keymodule i" therapeutic massager, which focuses on establishing substantial equivalence to previously cleared predicate devices. It describes the device, its intended use (reduction and improvement of secondary lymphedema of the arm post-mastectomy, and improvement of lymphatic circulation), and a comparison of its technological characteristics with predicate devices.

The document states: "This device is safe and effective as the predicate devices cited above. This is better expressed in the tabulated comparison (Paragraph 14 below)". However, the "tabulated comparison" (Paragraph 14) only compares technological characteristics such as indications for use, target population, design, materials, etc., and asserts "Identical" or "Similar" for many categories. It does not provide performance metrics, acceptance criteria, or a study demonstrating that the Cellu M6 Keymodule i meets specific performance targets for lymphedema reduction or lymphatic circulation improvement.

Therefore, I cannot generate the requested table or details about a study from the provided text.

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