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510(k) Data Aggregation

    K Number
    K222098
    Device Name
    ManaSport+
    Manufacturer
    ManaMed, Inc.
    Date Cleared
    2023-03-08

    (233 days)

    Product Code
    IMI, PFW
    Regulation Number
    890.5300
    Why did this record match?
    Applicant Name (Manufacturer) :

    ManaMed, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Apply stationary use of ultrasound to: Generate deep heat within body tissues for the treatment of selected medical conditions such as the relief of muscle spasms, the treatment of joint contractures, and the local increase in circulation. Apply continuous movement of ultrasound for: 1. Pain. - 2. Pain relief, muscle spasms, and joint contractures. - 3. Relief of pain, muscle spasms, and joint contractures that may be associated with: - · Adhesive capsulitis, - · Bursitis with slight calcification, - · Myositis, - · Soft tissue injuries, and - · Shortened tendons due to past injuries and scar tissues. - 4. Relief of pain, muscle spasms, and joint contractures resulting from: - · Capsular tightness, and - · Capsular scarring. - 5. Localized increase in blood flow. - 6. Increased range of motion of contracted joint using heat and stretch techniques.
    Device Description
    The ManaSport+ is an adaptation of the previously cleared ManaSport device, which was cleared under K210284. A wireless control option was added to the ManaSport+ and the subject device was evaluated for home use. As a portable and rechargeable prescriptive device in the home or clinical/hospital setting, the subject device is intended to apply ultrasound to the patient's treatment site for selected medical conditions such as the relief of pain, the relief of muscle spasms, the treatment of joint contractures, and the local increase in circulation. Ultrasound can be used to apply therapeutic deep heat for the treatment of selected medical conditions such as soft tissue injuries, shortened tendons due to past injuries and scar tissues, relief of pain, muscle spasms and joint contractures.
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    K Number
    K210284
    Device Name
    ManaSport
    Manufacturer
    ManaMed, Inc.
    Date Cleared
    2022-04-26

    (448 days)

    Product Code
    IMI, PFW
    Regulation Number
    890.5300
    Why did this record match?
    Applicant Name (Manufacturer) :

    ManaMed, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Apply stationary use of ultrasound to: Generate deep heat within body tissues for the treatment of selected medical conditions such as the relief of muscle spasms, the treatment of joint contractures, and the local increase in circulation. Apply continuous movement of ultrasound for: 1. Pain. - 2. Pain relief, muscle spasms, and joint contractures. - 3. Relief of pain, muscle spasms, and joint contractures that may be associated with: - · Adhesive capsulitis. - · Bursitis with slight calcification, - · Myositis, - · Soft tissue injuries, and - · Shortened tendons due to past injuries and scar tissues. - 4. Relief of pain, muscle spasms, and joint contractures resulting from: - · Capsular tightness, and - · Capsular scarring. - 5. Localized increase in blood flow. - 6. Increased range of motion of contracted joint using heat and stretch techniques.
    Device Description
    Not Found
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    K Number
    K211253
    Device Name
    PlasmaWave
    Manufacturer
    ManaMed, Inc.
    Date Cleared
    2021-05-26

    (30 days)

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

    ManaMed, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PlasmaWave is intended to be an easy to use portable system, prescribed by a physician, for use in the home or clinical setting to help prevent the onset of DVT in patients blood flow in the extremities (stimulating muscle contractions). This device can be used to: - · Aid in the prevention of DVT; - · Enhance blood circulation: - · Diminish post-operative pain and swelling; - · Reduce wound healing time; - Aid in the treatment and healing of stasis dermatitis, venous stasis ulcers, arterial and diabetic leg ulcers, chronic venous insufficiency and reduction of edema in the lower limbs. The unit can also be used as an aid in the prophylaxis for DVT by persons expecting to be stationary for long periods of time.
    Device Description
    The PlasmaWave is a lightweight, portable, rechargeable battery powered prescriptive device. It is intended to be used in the home or clinical setting by or under the direction of a medical professional to help stimulate blood flow as an aid in the prevention of deep vein thrombosis (DVT). The PlasmaWave utilizes pneumatically controlled, single-chamber wraps actuated by an electronically controlled unit of the air pump and solenoid valve via the tubing. All pump, battery and control components are protectively housed in a plastic case that is connected to a single use inflatable wrap via tubing. A Power On/Off button, a Mode (M) button, a Leg button, three LED indicators (Working, Charging, and Warming), and a LCD display provide user interface. There are also two tubing ports for connecting the tubing and a charging port for connecting the battery charger/AC adapter at the bottom of the control unit.
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    K Number
    K200351
    Device Name
    PlasmaFlight
    Manufacturer
    ManaMed, Inc.
    Date Cleared
    2020-08-05

    (175 days)

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

    ManaMed, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PlasmaFlight 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 cuffs. 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 PlasmaFlight is a portable and rechargeable device. It 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 cuffs. It can be used to temporarily increase blood circulation and temporarily relieve minor muscle aches and pains. The PlasmaFlight, supplied clean and non-sterile, utilizes the pneumatically controlled air bladder cuff actuated by an electronically controlled air pump unit. All pump, battery and control components are protectively housed in a plastic case of the control unit that is permanently attached to an inflatable cuff. An ON/OFF button and LED indicators/displays provide for user interface. There is also a port for connecting the battery charger/AC adapter plug. The cuff component consists of an air bladder encased inside a soft medical fabric or equivalent medical material for increased patient comfort and biocompatibility compliance. In operation, the user simply turns the power on via the ON/OFF button. A cuff containing the air bladder is permanently connected to the control unit. And the control unit then inflates the cuff to the default predetermined pressure (55 mmHg). The cuff pressure is monitored by an internal pressure switch and system software. Once the cuff pressure of the air bladder reaches the proper level, the pump is turned off for a rest period, and the cuff deflates to the ambient pressure through a valve inside the plastic case. After the rest period, the cycle of inflation and deflation repeats until the unit is turned off.
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