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510(k) Data Aggregation

    K Number
    K122744
    Device Name
    PROSPERA OTC TENS ELECTRONIC PULSE MASSAGER
    Manufacturer
    PROSPERA CORPORATION
    Date Cleared
    2013-03-28

    (202 days)

    Product Code
    NUH, NGX
    Regulation Number
    882.5890
    Why did this record match?
    Applicant Name (Manufacturer) :

    PROSPERA CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities.
    Device Description
    PL009 and PL009A are electrically powered devices intended for over the counter use and used to apply an electrical current to electrodes on a user's skin to relieve pain. It provides three selectable massage pulse styles with five auto operational modes through two channels with four attachment pads and shows graphic information about massage style, intensity and time remaining on a LCD based display which is incorporated with the device body. The device uses DC 6V power supplied by 4 AAA batteries. It is approximately 0.5lbs with dimensions 8" x 2" x 1" plus attachment pads. The only difference between PL009 and PL009A is the former has a button of "Repeat" representative of the function of repeat. PL029 is an electrically powered device intended for over the counter use and used to apply an electrical current to electrodes on a user's skin to relieve pain. It provides eight selectable massage pulse styles with five auto operational modes through two channels with four attachment pads and shows textual message about massage style, intensity and time remaining on a LCD based display which is incorporated with the device body. The device uses DC 3V power supplied by 2 AAA batteries. It is approximately 0.5lb with dimensions 8" x 2" x 1" plus attachment pads. The differences between PL009 and PL029 include: (1) PL009's work voltage is 6V supplied by 4 AAA batteries, while PL029's work voltage is 3V supplied by 2 AAA batteries. (2) PL009 provides three operational modes, i.e., massage, beat and knead, which can be combined into six stimulation programs for WAIST, SHOULDER, JOINT, HAND-FOOT, REPEAT and SOLE, while PL029 provides eight operational, i.e., massage, beat, knead, slim, acupuncture, scraping, cupping and immune. (3) PL009 uses mechanical potentiometer to control power and intensity, while PL029 uses electronic switches to control power and intensity. (4) PL009's LCD display shows body parts in graphics when the device is in operation, while PL029's LCD display shows working modes in text only when the device is in operation.
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    K Number
    K113544
    Device Name
    ELECTRONIC PULSE MASSAGER TENS ELECTRONIC PULSE MASSAGER
    Manufacturer
    PROSPERA CORPORATION
    Date Cleared
    2012-07-27

    (239 days)

    Product Code
    GZJ
    Regulation Number
    882.5890
    Why did this record match?
    Applicant Name (Manufacturer) :

    PROSPERA CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Symptomatic relief of acute post traumatic pain, acute post surgical pain, and chronic intractable pain. Prescription Use
    Device Description
    The Electronic Pulse Massager, which includes Models PL009, PL009A, and PL029, is a Transcutaneous Electrical Nerve Stimulator (TENS) for pain relief. TENS can help to relieve the pain caused by trauma or continual strain, and is suitable to be used on the user's back, neck, shoulders, legs, arms, and feet. The proposed Electronic Pulse Massager, which is compact, portable, and microprocessor-controlled, delivers a gentle electrical pulse to the underlying nerve through the wires and electrode pads placed on the skin of users. According to the need of users, the pulse intensity can be adjustable on the front control panel of the massager. Both Models PL009 and PL009A have five automatic stimulation programs and three manual programs, while Massager PL029 contains five automatic stimulation programs and eight selectable programs. The only difference between Models PL009 and PL009A is the former has a "REPEAT" program function and the latter does not. All these programs as well as the pulse intensity and time remaining can be displayed on the liquid crystal display screen of both massagers.
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