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The Normatec Elite is an air pressure massager intended to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas.

The Normatec Elite is a powered inflatable tube massager. It is intended to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas. It simulates manual kneading of tissues by the use of an inflatable pressure cuff. The devices are to be used by people who are in good health. The devices are charged and powered from an external compliant power supply. In addition, powered by an internal IEC 62133-2 compliant lithium-ion battery. The user interface on the Normatec Elite is a series of buttons with a small display the treatment time, pressure level, zone boost number. The user interface provides for: - Starting and stopping the massage treatment; . - . Adjusting time and intensity (pressure) of the treatment; - Selection of the zone to boost the pressure . In addition to the user interface on the devices, the proposed devices have Bluetooth capability that allows the use of a NormaTec app to control the device. The Bluetooth app allows the user to use a compatible Android or iOS phone to select and set device parameters listed above for convenience.

The Normatec Go is an air pressure massager intended to temporarily relieve minor muscle aches and to temporarily increase circulation to the treated areas.

The Normatec Go is a powered, inflatable tube, calf massager (Product Code "IRP"). It is intended to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas. The device is to be used by people who are in good health. The device is charged from an external compliant power supply and powered by an internal IEC 62133-2 compliant lithium-ion battery. The user interface on the Normatec Go is a series of buttons with one small display screen, to display the treatment time. located on the control unit mounted on the calf wrap. The user interface provides for: - . Starting and stopping the massage treatment; - . Adjusting time and intensity (pressure) of the treatment; In addition to the user interface on the proposed device, the device also has Bluetooth capability that allows the use of the NormaTec app to control the device. The Normatec app allows the user to use a compatible Android or iOS phone to select and set device parameters listed above for convenience

The Normatec 3 is an air pressure massager intended to temporarily relieve minor muscle aches and to temporarily increase circulation to the treated areas.

The Normatec 3 is a powered inflatable tube massager (Product Code "IRP"). It is intended to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas. It simulates manual kneading and stroking of tissues by the use of an inflatable pressure cuff. The devices are to be used by people who are in good health. The devices are powered from an external IEC 60601-1 compliant power supply and can also be powered by an internal IEC 62133-2 compliant lithium-ion battery. The user interface on the Normatec 3 is a series of buttons with one small display the treatment time. The user interface provides for: - Starting and stopping the massage treatment; . - Adjusting time and intensity (pressure) of the treatment; . - Selection of Attachment in use (Leg, Arm, Hip); . - . Selection of Zone Boost which provides an increase of 10 mm Hg to the Zone selected In addition to the user interface on the devices the proposed devices have Bluetooth capability that allows the use of a NormaTec app to control the device. The Bluetooth app allows the user to use a compatible Android or iOS phone to select and set device parameters listed above for convenience.

The NormaTec Pulse 2.0 and Pulse Pro 2.0 are air pressure massagers intended to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas.

The NormaTec Pulse 2.0 and Pulse Pro 2.0 are powered inflatable tube massagers (Product Code "IRP"). They are intended to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas. They simulate manual kneading and stroking of tissues by the use of an inflatable pressure ouff. The devices are to be used by people who are in good health. The devices are powered from an external IEC 60601-1 compliant power supply and can also be powered by an internal IEC 62133-compliant lithium-ion battery. The user interface on the Pulse Pro 2.0 model is 4.3" color TFT Screen with capacitive sensor (similar to a Smartphone). The user interface on the Pulse 2.0 model is 4.3" color LCD screen with smart switches. There is no difference in function between the two interface technologies, they are offered for marketing differentiation and user preferences. The user interface provides for: - . Starting and stopping the massage treatment; - . Adjusting time and intensity (pressure) of the treatment. In addition to the user interface on the devices, the proposed devices have Bluetooth capability that allows the use of a NormaTec app to control the Bluetooth app mimics the device interface graphics and buttons. allowing the user to use a compatible Android or iOS phone to control device functions just as if they were using the interface on the device. The app functionality is limited to mimicking the device interface and does not provide or unlock any additional features or alter the therapy provided by the device.

The NormaTec Pulse Rx 2.0 and Pulse Pro Rx 2.0 are intended to apply pressure to the extremities to treat: lymphedema and other edematous conditions, including congenital lymphedema praecox, and lymphedema tarda), post-mastectorny lymphedema, post-infection lymphedema, post-surgical lyphedema, post-radiation treatment lymphedema, venous insufficiency, venous stasis ulceration, and to prevent Deep Vein Thrombosis.

The NormaTec Pulse Rx 2.0 and Pulse Pro Rx 2.0 are Compressible Limb Sleeves (Product Code "JOW"). They simulate manual kneading and stroking of tissues by use of an inflatable pressure cuff. The devices are powered by an external IEC 60601-1 Power Supply and can also be powered by an internal IEC 62133-compliant lithium-ion battery.

The NormaTec PCD-T and NormaTec PCD-B are intended to apply pressure to the extremities to treat: Lymphedema and other edematous conditions, including - Congenital lymphedema (Millroy's disease, lymphedema praecox, ● - and lymphedema tarda) ● - Post-mastectomy lymphedema - Post-infection lymphedema ● - Post-traumatic lymphedema . - . Post-surgical lymphedema - Post-radiation-treatment lymphedema . - Venous insufficiency . - Venous stasis ulceration ● and to prevent: Deep Vein Thrombosis

The NormaTec PCD-T and PCD-B are designed to provide noninvasive air compression therapy for the treatment of lymphedema, venous insufficiency, other edemas, and venous stasis ulceration and to prevent deep venous thrombosis. They simulate manual kneading and stroking of tissues by use of an inflatable pressure cuff. The devices are powered from an external IEC 60601-1 compliant power supply and can optionally be powered by an internal lithium ion battery. The NormaTec PCD-T and PCD-B consist of an air compressor unit with a control system, an inflatable "appliance" (arms, legs and hips), plastic air tubing with proprietary connectors for connecting the device to the appliance; and an AC-DC adaptor with power cord. The inflatable leg and arm "appliances" and the plastic air tubing are of the same general design and constructions as those cleared in the predicate NormaTec PCD (K013436) the materials are identical. The hip appliance is identical to that in NormaTec's Pulse and Pulse Pro massagers cleared in 510(k) K160608 and uses identical materials. Additionally, the air compressor, valve control are similar to the predicate NormaTec PCD (and are identical to the NormaTec's Pulse and Pulse Pro massagers cleared in 510(k) K160608) The user interface on the PCD-T model is a 4.3"Color TFT Screen with Capacitive Sensor (similar to a Smartphone). The user interface on the PCD-B model is 4.3" Color LCD Screen, with Membrane Keypad with dome switches. There is no difference in function between the two interface technologies, they are just being offered for slight feature differences and user preferences.

The NormaTec Pulse and Pulse Pro is an air pressure massager intended to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas.

The NormaTec Pulse and Pulse Pro are powered inflatable tube massagers. They are intended to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas. They simulate manual kneading and stroking of tissues by use of an inflatable pressure cuff. The device is to be used by people who are in good health. The devices are powered from an external IEC 60601-1 compliant power supply and can optionally be powered by an internal lithium ion battery. The NormaTec Pulse and Pulse Pro consist of an air compressor unit with a control system, an inflatable "appliance" (arms, legs and hips), plastic air tubing with proprietary connectors for connecting the device to the appliance; and an AC-DC adaptor with power cord. The inflatable leg and arm "appliances", and the plastic air tubing are identical to the components of the FDA-cleared NormaTec MVP (K112890). The hip appliance is of the same general design and uses identical materials. Additionally, the air compressor, valve, valve control are similar to the predicate NormaTec MVP. The user interface on the Pulse Pro model is a 4.3"Color TFT Screen with Capacitive Sensor (similar to a Smartphone). The user interface on the Pulse model is 4.3" Color LCD Screen, with Membrane Keypad with dome switches. There is no difference in function between the two interface technologies, they are just being offered for slight feature differences and user preferences.

The NormaTec MVP is an air pressure massager intended to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas.

The NormaTec MVP is a powered inflatable tube massager. It is intended for medical purposes, such as to relieve minor muscle aches and pains and to increase circulation to the treated areas. It simulates kneading and stroking of tissues with the hands by use of an inflatable pressure cuff. The device is to be used by people who are in good health. The NormaTec MVP consists of an air compressor with a manual pressure adjustment bleed-valve, an inflatable appliance (boot or arm sleeve). plastic air fubing connecting the device to the appliances, and an AC/DC adaptor with power cord. The appliance is divided into 5 segments, with a single tube leading from each segment to the tubing connector on the device.