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510(k) Data Aggregation

    K Number
    K202044
    Device Name
    Powerpress Recovery Unit
    Date Cleared
    2020-10-21

    (90 days)

    Product Code
    Regulation Number
    890.5650
    Why did this record match?
    Applicant Name (Manufacturer) :

    Hanuri Distribution, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Powerpress Recovery Unit is indicated for the temporary relief of minor muscle aches and pains, and for temporary increase in circulation to the treated areas in good health. The Powerpress Recovery Unit simulates kneading and stroking of tissues by using an inflatable garment.
    Device Description
    Powerpress Recovery Unit is a sequential pneumatic compression device designed to apply compression to a limb. The device is composed of two components. Pneumatic Manual / Analog Pump. Limb Sleeve or garment composes of 4 chambers Powerpress Recovery Unit enables different treatment pressure (30 ~ 100mmHg). When activated, air flows into chamber, the pump provides gradient pressurization to the chambers (sequential inflation of distal to proximal, with distal chambers inflated to a greater pressure than the proximal ones). After each chamber is inflated, the pressure is held constant until all chambers are inflated, in order to prevent reverse gradient flow. Once all chambers are inflated, they are then all released simultaneously, and the cycle repeats. Pressure within chambers are adjustable pressure to chamber 1 is controlled by user-adjusted regulator on the pump. Pressure in chamber 2, 3 & 4 are individually lowered according to the default factory setting. Gradient: appx 7%, example: Foot 60mmHg – Ankle 56mmHg – Calf 52mmHg - Thigh 48mmHg Cycle Time: Inflation 36 sec / Deflation 24 sec Inflation time each chamber : 1st chamber(foot) – 36 sec, 2nd chamber(ankle) – 27 sec, 3rd chamber(calf) - 18 sec, 4th chamber(thigh) - 9 sec A calibrated dial gauge displays pressure in the range of 0 ~ 160 mmHg
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    K Number
    K110276
    Device Name
    POWERPRESS UNIT
    Date Cleared
    2011-11-09

    (282 days)

    Product Code
    Regulation Number
    870.5800
    Why did this record match?
    Applicant Name (Manufacturer) :

    HANURI DISTRIBUTION, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Powerpress Unit Sequential Circulator is a manual, sequential, pneumatic compression device, intended for the primary or adjunctive treatment of primary or secondary lymphedema. The device is also intended for the additional or alternate treatment of venous insufficiency, and chronic venous stasis ulcers associated with venous insufficiency, as well as general treatment of swelling of the extremities. The device is intended for home or hospital use.
    Device Description
    Powerpress Unit is a sequential pneumatic compression device designed to apply compression to a limb. The device is composed of two components: Pneumatic Manual Pump and Limb Sleeve or garment composes of 4 chambers. Powerpress Unit enables different treatment pressure (30 ~ 100mmHg). Treatment pressure and time should be used according to physician prescription. When activated, air flows into chamber, the pump provides gradient pressurization to the chambers (sequential inflation of distal to proximal, with distal chambers inflated to a greater pressure than the proximal ones). After each chamber is inflated, the pressure is held constant until all chambers are inflated, in order to prevent reverse gradient flow. Once all chambers are inflated, they are then all released simultaneously, and the cycle repeats. Pressure within chambers are adjustable - pressure to chamber 1 is controlled by user-adjusted regulator on the pump. Pressure in chamber 2, 3 & 4 are individually lowered according to the default factory setting. Gradient: appx 7%, example: Foot 60mmHg - Ankle 56mmHg - Calf 52mmHg -Thigh 48mmHg Cycle Time: Inflation 36 sec / Deflation 24 sec Inflation time each chamber : 1st chamber(foot) - 36 sec, 2nd chamber(ankle) - 27 sec, 3rd chamber - 18 sec, 4th chamber(thigh) - 9 sec. A calibrated dial gauge displays pressure in the range of 0 ~ 160 mmHg.
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