Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K122154
    Device Name
    POWERPLAY MUSCLE MASSAGER
    Manufacturer
    FIG, LLC
    Date Cleared
    2012-11-21

    (124 days)

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

    FIG, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PowerPlay model PPRT-01 is intended to be an over-the-counter portable inflatable tube massage system which simulates kneading and stroking of tissue with the hands by use of inflatable pressure wraps. This device can be used to: - . Temporarily increase blood circulation in the treated areas; - . Temporary relief of minor muscle aches and pains.
    Device Description
    The PowerPlay Muscle Massager is a lightweight, portable, rechargeable battery powered OTC device that is intended to be used by individuals to relieve minor muscular aches and pains and to temporarily increase blood circulation in the treated arcas. The system utilizes pneumatically controlled, single bladder compression wraps actuated by an electronically controlled air pump unit and solenoid valves. The intermittent compression provided by the system simulates stroking and kneading of the hands. All pump, battery and control components are protectively housed in a plastic case. A mylar control panel overlays 4 tactile touch control switches, an LED display for monitoring pressure, LED "selected channel", "low battery" and "charging" indicators. There is also a port for connecting the battery charger/AC adapter plug. The compression wraps consist of a Polyvinyl Chloride (PVC) air bladder encased inside soft, non-woven medical fabric (made from Polyester or Softesse - a fabric composed of common kitchen sponge material), which is adhered to the PVC air bladder. The wraps are supplied clean, non-sterile, packaged individually. A calf, ankle, knee, hip or shoulder massage wrap may be supplied with the PPRT -01 system or available as accessory items. In operation, the user selects any number of 3 different outputs (Port 1, Port 2 and/or Port 3) and sets the pressure desired for each port (30, 50 or 70 mmHg). An LED corresponding to each output indicates the selected ports, with the digital display indicating the pressure setting for each (see instructions for use). User determined compression wraps containing air bladders are connected to the unit via externally accessible plastic quick-disconnect air ports. The control unit then inflates the wraps to the preset pressure. The LED that corresponds to the activated output channel flashes slowly while that wrap is being filled with air. Wrap pressure is monitored by an integrated pressure transducer and system software. Once the pressure reaches the proper level, the pump is turned OFF for a predetermined "rest" period, and the wrap deflates to ambient pressure through a valve inside the plastic case. After the "rest" period, the next wrap is sequenced, and so on. This cycle repeats for 20 minutes on each output (preset treatment period) and then that output turns off. When all selected outputs have completed their 20 minute treatment period the unit powers off. The unit power can be turned off at any time by pressing and holding the I/O button for approximately 2 seconds. The "rest" period is internally preset to allow each wrap approximately 30 seconds between inflations in order to ensure adequate deflation time between compressions. When multiple outputs are selected, only one wrap is inflated at a time.
    Ask a Question

    Page 1 of 1