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510(k) Data Aggregation
(164 days)
The AIR COMPRESSION BOOTS is intended for the temporary relief of minor muscle aches and pains and for temporary increase in blood circulation to the treated areas in people who are in good health. The AIR COMPRESSION BOOTS simulates kneading and stroking of tissues by using an inflatable garment.
This product operates through an air pump stored internally, sending air into the air bag, inflating and deflating through the alternate work of the solenoid valve, and squeezing the leg to achieve a massage effect. This product consists of hand controller, air pump, air valve and leg bag. The following model numbers are identical in circuitry and electrical, mechanical and physical construction; the only differences are the size and model number for trading purpose. The model 1018196 is for the 26-inch size and model 1018195 is for the 32-inch size.
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(29 days)
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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(281 days)
This device is intended for use only in adult patients.
Therapeutic Ultrasound
Application of therapeutic deep heat for the treatment of selected sub-chronic and chronic medical conditions such as:
- Pain relief, muscle spasms and joint contractures.
- Relief of pain, muscle spasms and joint contractures that may be associated with:
- Adhesive capsulitis
- Bursitis with slight calcification
- Myositis
- Soft tissue injuries
- Shortened tendons due to past injuries and scar tissues
- Relief of sub-chronic, chronic pain and joint contractures resulting from:
- Capsular tightness
- Capsular scarring
For TENS, Interferential, premodulated (IFC), NMS and Microcurrent:
- Symptomatic relief of chronic intractable pain
- Post-traumatic acute pain
- Post-surgical acute pain
Additionally for NMS, NMS Burst, Hi-Volt and Russian:
- Relaxation of Muscle spasms
- Prevention or retardation of disuse atrophy
- Increasing local blood circulation
- Muscle re-education
- Maintaining or increasing range of motion
- Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis
For DC Continuous Mode
- Relaxation of muscle spasm
The Ultrasound Therapy Workstation (model: XMS-UET2) is an AC-powered device designed to use electrical stimulation and therapeutic ultrasound. Key features include ultrasound output and electrical stimulation output. This device is intended for use in healthcare environments such as hospitals, rehabilitation centers, community health service centers, and clinics.
The device has a color touchscreen display and a control knob with light ring. The screen display shows system information to the user. Both display screen and control knob can assist the user in selecting or adjusting parameters. All controls and indicators are controlled by software.
Three non-invasive therapeutic methods are available: electrotherapy, ultrasound therapy and combination therapy (ultrasound plus electrical stimulation). For each method, the device is configured with protocols and manual operation, which can facilitate users to choose pre-set protocols or adjust parameters to suit individual needs.
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(137 days)
It is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.
The product is intended only carry one person and used as a means of transportation for the disabled, the sick and the infirm. The electric wheelchair is classified as class A and the maximum occupant mass is 120kg. The Electric Wheelchair is a battery powered vehicle. It consists one Lithium battery with an off-board battery charger, frame, controller, motors, seat, back support, control device (including the battery power indicator light, ON/OFF button, horn button, speed indicator, speed increase button, speed decrease button, joystick, battery charger socket), arm supports, push handle, two rear wheels, two casters(front wheels), foot supports, anti-tip devices. The wheelchair can easily fold and unfold for transportation or storage.
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(59 days)
It is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.
The Folding mobility scooter, has a base with metal frame, two front wheels, two rear wheels, a seat, a LED Display, electric motor, electromagnetic brake, 1 rechargeable Lithium Battery pack (with 2 batteries) with an off-board charger. The movement of the scooter is controlled by the rider who operates the control lever. The device is installed with an electromagnetic brake that will engage automatically when the scooter is not in use and the brake cannot be used manually. The Scooter only can be operated on the flat road. The device can be folded up from front to back.
The device has 2 options, with a faucet adjustment or without a faucet adjustment.
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(53 days)
The manual wheelchair is to provide mobility to persons limited to a sitting position.
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(110 days)
It is motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.
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(48 days)
The electric wheelchair is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.
The Electric wheelchair, Model P2, is an indoor/outdoor, foldable, battery-operated 2-wheel (rear-wheel drive) powered wheelchair. It consists of two parts: the electrical part and the wheelchair main body. The electric part includes brushless motor, electromagnetic brake system, controller, rechargeable Lithium-Ion battery and off-board battery charger. The main parts of the wheelchair include front wheels, rear wheels, frame, armrest, backrest and seat cushion.
The control system, including the controller handle (joystick), is equipped on the control board that attaches to the one of the arm rests. When the joystick is released, the electromagnetic brakes will be actuated, and the power wheelchair is slowed to a stop.
The electric wheelchair can be folded/ expanded manually. The Left and right handrails (joystick) can be interchange.
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(90 days)
The Normatec Elite Hip 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 Hip 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 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 Hip is a series of buttons with a small display screen to 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.
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(112 days)
The Air compression therapy device(K1002K1102/K1006/K1007/K1008/K1061 ) is an air pressure massager intended to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas.
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