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Cryon-X Pro
The private-label Cryon-X Pro device combines cold, heat, contrast, and compression therapy. It is intended to treat post-surgical and acute 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) is indicated.

The device may optionally provide DVT therapy, intended to reduce the risk of the formation of deep venous thrombosis (DVT) by aiding blood flow back to the heart via lower extremity limb compression.

This device is intended to be used by or on the order of licensed healthcare professionals in rehabilitation facilities, outpatient clinics, athletic training settings, and home settings.

Cryon-X One
The private-label Cryon-X One device combines cold and compression therapy. It is intended to treat post-surgical and acute injuries to reduce edema, swelling, and pain for which cold and compression are indicated. It is intended to be used by or on the order of licensed healthcare professionals in rehabilitation facilities/hospitals, outpatient clinics, athletic training settings, and home settings.

This submission includes two models JKH-152 (private labelled as Cryon-X Pro) and JKH-151 (private labelled as Cryon-X One) as the subject devices. The private-label Cryon-X Pro has all the same features of combining cold, heat, contrast, and compression therapies as its original 510(k) cleared device in K223541, and Cryon-X One has the simplified features of cold and compression, which are the same as those of its original 510(k) cleared device in K223541. Each of the subject devices is an AC powered, software-controlled multimodality device, intended to be used by or on the order of licensed healthcare professionals in rehabilitation facilities/hospitals, outpatient clinics, athletic training settings, and home settings.

The subject device is a prescriptive device, which is intended to treat post-surgical and acute 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 are indicated. It is optionally intended to reduce the risk of the formation of deep venous thrombosis (DVT) by aiding blood flow back to the heart via lower extremity limb compression.

The subject device and its accessories are clean and non-sterile. The device has a power switch, and then conducts the remaining operations on its touch screen, including the treatment temperature adjustment, air compression adjustment, and treatment time adjustment. The device works by circulating cooled or heated water and air through a treatment wrap that is placed on the treatment body area. The cooled or heated water circulates through the treatment wrap and provides cold or hot therapy, and the air compression inflates and deflates the treatment wrap to compress around the treatment body area. A connecting tube/hose is used to connect the device to the treatment wrap. The disposable or reusable wraps come with a variety of options to cover different body areas, including the universal, back, shoulder, ankle/foot, hip, knee, etc. To avoid any potential adverse skin reactions such as redness, irritation, and cod/hot injury, the sock/clothing should be worn by the patient prior to use.

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