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The Heat Exchange Equipment for Cryotherapy and Thermotherapy provides a combination of cold, heat, contrast, and compression therapies. It is intended to treat post-surgical and trauma injuries to reduce edema, swelling and pain, for which cold and compression are indicated. It is intended to treat post traumatic and post-surgical medical and/or surgical conditions, for which localized thermal therapy (hot or cold or contrast) are indicated. The equipment is intended to be used by, or on the order of, licensed health care professionals in rehabilitation facilities, outpatient clinics, and athletic training settings.

The Heat Exchange Equipment for Cryotherapy and Thermotherapy (Z-ONE, ZT Cube and ZT Clinic) are AC-powered, software-controlled multi-modality devices, designed to impart localized heat exchange and compression therapies. The devices have been developed with the possibility of choosing between different programs: cold therapy, heat therapy and contrast therapy (alternating hot and cold). Moreover, they also possess an intermittent pneumatic compression activity, which is the effect of an alternance of compression and decompression. The compression activity is available in four different levels: minimum (15 mmHg), low-medium (40 mmHg), medium (60 mmHg) and maximum (80 mmHg). It is also possible for the professional user to select the duration of the pulsed compression. With heat treatment, only a low compression level, i.e. 15 mmHg can be selected. The device allows for a maximum treatment time of 30 minutes for heat therapy, 90 minutes for cold therapy, and 90 minutes for contrast therapy. The devices are designed to be compatible with a series of Thermal Wraps, that are available for different parts of the body: full leg, shoulder, thigh, knee, calf, elbow, wrist, ankle and hip. The devices are designed to be used in rehabilitation facilities, outpatient clinics, and athletic training settings, by, or on the order of, licensed health care professionals. The Heat Exchange Equipment for Cryotherapy and Thermotherapy is available in 3 different models: - **Z-ONE:** portable unit with a comfortable handle for moving. This model is developed to deliver only cold therapy, with a temperature range between 41°F and 59°F (5°C - 15°C) and it allows the connection of up to two wraps at the same time and therefore the possibility to treat more patients using the same program simultaneously. - **ZT Cube:** portable unit with a comfortable handle for moving. This model allows the delivery of cold therapy, heat therapy and contrast therapy (alternating hot and cold), with a temperature range of 34°F as minimum and 104°F as maximum (1°C - 40°C). Up to two wraps can be connected at the same time. - **ZT Clinic:** unit designed and built for the complex needs of clinics and hospitals, as it can suit up to 4 thermal wraps simultaneously. This model can be used to deliver cold therapy, heat therapy and contrast therapy, alternating hot and cold. Temperature range is 34°F as minimum and 113°F as maximum (1°C - 45°C). The devices are controlled by an intuitive touch screen computer interface, allowing the user to manage the therapy modalities as well as easily adjust and monitor treatment times, temperature and compression settings.

The Air Compression Leg Massager is used to temporarily relieve mild muscle pains and discomfort, and temporarily increase blood circulation to the treatment areas in people who are in good health. Air Compression Leg Massager simulates kneading and stroking of tissues by using an inflatable garment.

Air Compression Leg Massager 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 models include UM605, UM606, UM607, UM608，UM609，UM610, UM611, UM617. All of them have same Indications for use, technological characteristics and similar device appearance. And they have the same electrical circuit design, PCB layout, critical components and internal wiring. The differences for them are software function, operation method for mode adjustment and the shape of compatible inflatable garment. Air Compression Leg Massager supplied clean and non-sterile, utilizes the pneumatically controlled leg wraps actuated by an electronically controlled air pump unit. A pump, battery and control components are protectively housed in a plastic case of the main body. The main body and the inflatable garment are not detachable. Function buttons and light emitting diode (LED) indicators on the main body make up the user interface. Each inflatable garment is connected to the main body by air hoses and encase a 2-chamber air bladder inside. Calves can be wrapped and massaged separately by the two chambers. The main unit is directly installed on the inflatable garment through tubes and fixing buckles, and there is no need for users to install it again. The soft medical fabric of wraps provides patient comfort and biocompatibility compliance. In operation, the user turns the power on via the Power button. Then the main body controls the inflating and deflating of the air bladders according to preset program.

Air Compression Leg Massager is indicated for the temporary relief of minor muscle aches and pains and for temporary increase in circulation to the treated areas in people who are in good health. Air Compression Leg Massager simulates kneading and stroking of tissues by using an inflatable garment.

Air Compression Leg Massager is a portable and rechargeable device. It is intended to be an over-the-counter portable inflatable tube massage system which simulates kneading of tissue with the hards by use of inflatable presure cuffs. It can be used to temporarily increase blood circulation and temporarily relieve minor muscle aches and pains. Air Compression Leg Massager supplied clean and non-sterile, utilizes the pneumatically controlled by an electronically controlled air pump unit. A pump, battery and control components are protectively housed in a plastic case of Controller. Function buttons and light emitting diode (LED) indicators on the user interface. There is a charging port at the bottom of Controller for connecting the alternating current (AC) adapter plug. Each leg wap has an air hose for connection to Controller, and both encase a 2-chamber air bladder inside. It can be wrapped and massaged separately by the two chambers. The soft medical fabric of wraps provides patient comfort and biocompatibility compliance. Air Compression Leg Massager is also capable of providing the warming and vibration, these are included for an improved user experience.

The Air Compression Massager 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 Air compression massager 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 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 by an internal IEC 62133-2 compliant lithium-ion battery. The user interface on the Air compression massager is a series of buttons with a small display screen to display the treatment time, pressure level, mode and chamber status. The user interface provides for: Starting and stopping the massage treatment; Adjusting treatment related parameters such as treatment time and pressure level etc.; Selection of the chamber to boost the pressure. In addition to the user interface on the devices, the subject device have Bluetooth capability that allows the use of a Beoka 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 product is provided non-sterile, and not to be sterilized by the user prior to use. All models in this submission are the same except for the color of controller and button shape.

The Game Ready system is indicated for the temporary relief of minor muscle aches and pains. The device is indicated for temporary increase in circulation of the treated areas in people who are in good health, and simulate kneading and stroking of tissues using an inflatable wrap. The Game Ready system is indicated for localized therapy in situations where cold temperature therapy is necessary or desirable.

Game Ready system (550500-04); Game Ready Control Unit (550550-04); Game Ready Full Leg Boot Wrap - Medium (590923-04); Game Ready Full Leg Boot Wrap - Large (590922-04); Game Ready C-T Spine Wrap (590502-04); Game Ready Half Leg Boot (590906-04); Game Ready Back Wrap (590500-04); Game Ready Hand/Wrist Wrap (590811-04); Game Ready Flexed Elbow Wrap (590903-04); Game Ready Straight Elbow Wrap (590200-04); Game Ready Shoulder Wrap, Medium, Right (590422-04); Game Ready Shoulder Wrap, Large, Right (590432-04); Game Ready Shoulder Wrap, Medium, Left (590424-04); Game Ready Shoulder Wrap, Large, Left (590434-04); Game Ready Hip/Groin Wrap, Right (590602-04); Game Ready Hip/Groin Wrap, Left (590604-04); Game Ready Straight Knee Wrap (590100-04); Game Articulated Knee Wrap (590160-04); Game Ready Ankle Wrap, Large (590330-04); Game Ready Ankle Wrap, Extra Large (590340-04)

The Air Pressure Therapy System is intended to temporarily relieve minor muscleaches and/or pains, and to temporarily increase circulation to the treated areas in people who are in good health.

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The ElastiMed's SACS PRO device is a portable and lightweight device intended to provide compression in both sustained and intermittent settings and by so doing, aids in the stimulation of blood flow in the legs. The SACS PRO device is intended to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas. The device can be used in Clinics, hospital, athlete training, and home environments.

The ElastiMed SACS PRO is a lightweight, portable battery powered device, aiding in the stimulation of blood flow in the lower limb through sequential compression. The SACS PRO device imbeds three Electro Active Polymer (EAP) straps, that sequentially stretch and contract when stimulated by an electric charge. The timely sequential upward contractions of the straps compress the limb, allowing for the repetitive squeezing and relieving actions that mimic normal muscle contractions. The device is supplied with a rechargeable battery which is incased in the fabric casing, and a microprocessor which is imbedded within the control box, located at the front of the one touch operation control box also imbeds a buzzer, LED light indicator, micro speaker, and a micro-USB port (for charging). The device can be used in Clinics, hospital, athlete training, and home environments.

Leg Massager (Models:RP-ALM070H, RP-ALM071H) is intended for home to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas in people who are in good health.

Leg Massager (Models:RP-ALM070H, RP-ALM071H) is consist of air pressure sensor, air pump, sleeves etc working together as one unit. The air pump is connected to the dedicated sleeves via a series of hoses. The compression massage direction is from limb end to body center by inflating the air chambers sequentially and then deflating as one cycle, the pressure can be adjusted to avoid any discomfort to the patient. The sleeve works under the action of sensor and microprocessor. Leg Massager (Models:RP-ALM070H, RP-ALM071H), in medical market, it has a sequential squeezing from distal to proximal, thus help to improve circulation to the treated areas.