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510(k) Data Aggregation
K Number
K131387Device Name
WRIGHT GRADIENT 52 - TORSO
Manufacturer
Date Cleared
2013-11-20
(190 days)
Product Code
Regulation Number
870.5800Why did this record match?
Applicant Name (Manufacturer) :
WRIGHT THERAPY PRODUCTS, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Wright Gradient 52 - Torso and Wright 51 - Torso are for treatment of lymphedema, venous insufficiencies, and other edematous conditions.
Device Description
The Wright Gradient 52 - Torso and Wright 51 - Torso consists of a pneumatic compression pump, a hose assembly, and associated inflatable appliances. It is typically used to compress upper and lower body extremities and portions of the torso.
The pump consists of an enclosure that contains a small air compressor, solenoid valves, printed circuit board including a programmable microprocessor, graphic display, and associated electronic circuits and pneumatic connections. Software controls the sequential. opening and closing of the solenoid valves, which are connected to five (5) external pressure ports.
The appliance assembly is made of fabric and consists of one or two limb appliances (for an arm or a leg) and a torso appliance (for abdomen or chest area). Each limb appliance comprises four cells, with the dimensions of the appliance dependent upon the physician's order and the patient's limb measurements. There are two basic variations of the torso appliance: (1) a vest-like appliance for compression of the upper torso; and (2) a girdle-like appliance for compression of the lower torso. In each case the dimensions of the appliance dependent upon the physician's order and the patient's anatomical measurements.
In operation, the pump fills the inflatable appliance(s) with air to compress the prescribed limb(s) and torso area with the prescribed pressures in a preset therapy program. The therapy program is based on manual fymph drainage massage principles and intended to improve ymphatic and venous return circulation for the patient.
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