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510(k) Data Aggregation
K Number
K053225Device Name
CELLU M6 KEYMODULE I
Manufacturer
LPG ONE, INC
Date Cleared
2006-11-06
(354 days)
Product Code
ISA
Regulation Number
890.5660Why did this record match?
Applicant Name (Manufacturer) :
LPG ONE, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Reduction of Secondary Lymphedema of the Arm (SLA) Post Mastectomy Improvement of Secondary Lymphedema Improvement of lymphatic circulation in the treated area
Device Description
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.
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