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For Over-The-Counter Use: TENS: ManaFlexx 2 (MF002-OTC) is used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, arm, and leg, due to strain from exercise or normal household and work activities. ManaFlexx 2 (MF002-OTC) is also intended for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis. PMS/NMES: ManaFlexx2 (MF002-OTC) is used to stimulate healthy muscles in order to improve and facilitate muscle performance. To be used for the improvement of muscle tone and firmness, and for strengthening muscles in the arms, abdomen, legs, and buttocks. Not intended for use in any therapy or for the treatment of any medical conditions or diseases. ManaFlexx2 (MF002-OTC) is also intended to temporarily increase local blood circulation in the healthy muscles of lower extremities. For Prescription Use: TENS: ManaFlexx2 (MF002-RX) is intended for the following use: - Symptomatic relief and management of chronic, intractable pain - Adjunctive treatment for post-surgical and post-trauma acute pain - Relief of pain associated with arthritis PMS/NMES: ManaFlexx2 (MF002-RX) is intended for the following use: - Temporary relaxation of muscle spasm - Prevention or retardation of disuse atrophy - Muscle re-education - Maintaining or increasing range of motion - Increase of local blood flow in the treatment area - Prevention of post-surgical venous thrombosis through immediate stimulation of calf muscles

The ManaFlexx 2 delivers electric pulse generated to the user's body areas through the electrodes. The device has two program modes of different pulse frequencies, covering TENS and PMS/NMES. The main unit is egg shape, includes operating elements, such as the ON/OFF button, intensity increase button and intensity decrease button, and there are two snap connectors on the rear of the device which are for connecting with electrode. The device could be easily operated through its buttons to manually realize its functions, such as turning on/off and increasing/decreasing intensity, and there is a LED screen to display the selected mode, intensity level and charging status. The electrode is a long strip shape with a size of 21cm x 5.3cm, its conductive part is black color, and there is white non-conductive area with a width of 1 cm in the middle, which divides the electrode into two parts: positive and negative. There are 2 snap connectors on the electrode used for connection with main unit. The device has two models have the same appearance, the identical hardware and software, only the model names are different and model MF002-Rx is for prescription use and MF002-OTC is for OTC 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.

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.

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.

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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.

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.

The ManaFlow system, part numbers MFLOW51 and MFLOW52, is comprised of a gradient compression sleeve and a portable intermittent pump to provide graduated compression in both sustained and intermittent settings for use in both the hospital and outpatient setting. ManaFlow 51 is pre-set to the default setting of 50 mmHg and cannot be adjusted, whereas the ManaFlow 52 can be adjusted by the physician to a pressure within the specified range. It is intended for use in: - · Treatment of lymphedema - · Treatment of chronic venous insufficiency - · Treatment and promotion of healing of stasis dermatitis and venous stasis ulcers - · Reducing venous leg ulcer healing time - · Reducing edema due to venous stasis - Enhancing venous return The device is intended for home, and hospital use.

The ManaFlow system, part numbers MFLOW51 and MFLOW52, is a portable and rechargeable prescriptive device. It is intended to be used in the home or clinical/hospital setting by or under the direction of a medical professional to apply pressure to treat lymphedema and other edematous conditions and to prevent Deep Vein Thrombosis (DVT). The ManaFlow, supplied clean and non-sterile, utilizes the pneumatically controlled 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 attached to an inflatable cuff/sleeve. An ON/OFF button, a SET button, and a display provide for user interface. There is also a port for connecting the battery charger/AC adapter plug. The cuff component consists of multiple (four or so) air chambers/bladders encased inside a soft medical fabric or equivalent medical for increased patient comfort and biocompatibility compliance. In operation, the user simply turns the power on via the ON/OFF button. A cuff containing air chambers/bladders is connected to the control unit. And the control unit then inflates the cuff to the default pre-determined pressure (50 mmHg), which could be adjusted/calibrated via the SET button. The cuff pressure is monitored by an internal pressure switch and system software. Once the cuff pressure of the multiple air chambers/bladders reaches the pre-determined or adjusted level, the pump is turned OFF for a rest period, and the cuff deflates to ambient pressure through a valve inside the plastic case. After the rest period, the cycle of inflation and deflation repeats until the device is turned off.

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.

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.

The PlasmaFlow, model PF0001, 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 by stimulating blood flow in the extremities (simulating 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.

The PlasmaFlow is an ambulatory, portable, light weight, prescriptive intermittent pneumatic compression system intended to provide sequential compression therapy to a patient's lower limbs. All pump control unit components are protectively enclosed in a plastic casing which is fixated to a single chamber cuff. The unit is supplied with a nonserviceable, rechargeable battery, to allow user portability, and a power supply transformer for main connection. The PlasmaFlow is an ambulatory, portable, light weight, prescriptive device intermittent pneumatic compression system intended to provide sequential compression therapy to a patient's lower limbs. The housing on the garment is a lightweight, rechargeable battery-powered, electromechanical control unit intended to provide and digitally monitor through two LED screens the inflation cycle for enhanced circulation therapy. The controller on the sleeve allows the unit to inflate distal to proximal. It is intended to be used in the home, travel situations where altitude or lack of mobility occurs, 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). All pump control unit components are protectively enclosed in a plastic casing which is fixated to a single chamber cuff. The unit is supplied with a non-serviceable, rechargeable battery, to allow user portability, and a power supply transformer for main connection. The pump has two LED screens. The screen allows the prescriber and or patient to verify the pressure, the mode, and total run time. The Patient Sleeve is a single Polyvinyl Chloride (PVC) air bladder intended to be attached directly to the patient's lower limb. It is intended to provide compression action to the tissue surrounding the venous vasculature in the calf of a patient. A compression unit with two LED screens is connected to sleeve for a completely ambulatory system. The compression unit has the ability to produce different compression modalities. Default modality will be the same as the predicated devices, which is, a slow inflation up to 55 mmHg of air through the bladder cells. Once pressure is reached, the unit will deflate for approximately 50 seconds. Then the cycle repeats. Another compression modality will be the step up technology that inflates the air cells at an increase of 10 mmHg pausing at increments of ten to 50 mmHg, with a final increase of 5 mmHg to 55mmHg. Once 55 mmHg is reached, the unit will decrease to 50 mmHg and then decrease in increments of 10 mmHg. A single touch control switch located on the top of the unit powers on the unit and switches the mode. Above the power button, a dual color LED light allows the user to verify for power on, low battery, charging and charge completed indication, and an audible alarm (for indicating a leak or low pressure alarm) provides for user interface. There is also a port for connecting the battery charger/AC adapter plug/USB chord. The leg wrap (cuff) component consists of a Polyvinyl Chloride (PVC) air bladder encased inside a soft, non-woven medical fabric made from a Polyester blended medical fabric or equal, which is adhered to the PVC air bladder. The units are supplied clean, non-sterile, packaged in pairs. In operation, the user simply runs the power ON via the multi-purpose control button. A single user "cuff containing air bladders is connected to the unit. The control unit then fills the cuff to a pressure of 55 mmHg. Cuff pressure is visually monitored by user pressure LED screen, internal pressure switch, and system software. Once the pressure reaches the proper level, the pump is deflated for an approximately 50 second deflate period. The device software ensures the cycle time is a minimum of 60 seconds (the cycle time is the length of time for one complete cycle on one cuff including fill time, exhaust, and relaxation time). The cycle repeats until the unit is turned off.