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Electro-Light Therapy System is used to provide topical heating for: - Temporary increases in local blood flow and circulation . - . Temporary relief of minor muscle and joint aches - . Temporary relief of pain and stiffness - . Relaxation of muscles - . Temporary relief (or relaxation) of muscle spasms - . Temporary relief of minor pain and stiffness associated with arthritis The Electro-Light Therapy system is intended to be used alone or at the same time with legally marketed powered muscle stimulators, TENS units or Interferential Current Therapy when used with the transparent Electro-Light electrode.

The Electro-Light Therapy offers similar infrared therapy to the K072256 predicate device. The IR Light covered by K072256 allowed the operation of only one light head. The Electro-Light Therapy can support up to 4 light heads each with a similar intensity to the predicate K072256. The Electro-Light Therapy device can shine its IR light through the optional transparent gel electrodes. The Electro-Light Therapy is intended be used with any legally marketed TENS, interferential, or powered muscle stimulator. The IR and visible light will pass through a clear gel electrode. The gel electrode was cleared under K072256. Like the predicate devices, the Electro-Light Therapy is intended to be used only by a qualified therapist. Both the predicate devices and the new device are intended to be used on a cart. The new device has a maximum time setting of 99 minutes.

The Aklarus Blue (420nm +/-10nm), is generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris. The Aklarus combination of Red (628nm +/-10nm) and Blue (420nm +/-10nm) is intended to emit energy in the red, blue regions of the spectrum to treat dermatological conditions, specifically indicated to treat mild to moderate acne vulgaris. The Aklarus Anti-Aging Red (628nm +/-10nm) and Anti-Aging Infrared (880nm +/- 10nm) Combination is intended to emit energy in the red and infra-red region of the spectrum for use in dermatology for the treatment of periorbital wrinkles. The Alarus Infrared (880nm +/-10nm) is intended to emit energy in the IR spectrum to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation where applied.

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The HF54 interferential therapy and premodulated therapy is indicated for: Pain relief for: Symptomatic relief of chronic intractable pain and/or management of traumatic or post surgical pain. Ultrasound therapy is available from the HF54 and indicated for: Applying therapeutic deep heat within body tissues for the treatment of selected chronic and sub-chronic medical conditions such as: Relief of pain joint contractures This can be done using One or two ultrasound applicators. The second ultrasound applicator is optional. Ultrasound therapy, either alone or in combination with interferential therapy or premodulated therapy can be used in a scanned manner (where the therapist moves the applicator) or for specific treatment areas identified in the operator's manual, the applicator can be used in a hands-free manner (where the applicator remains stationary). An Infrared Therapy Probe is available as an optional accessory (HF023) for use with the Hill Laboratories HF54 Combination Ultrasound Interferential and premodulated stimulation system or for stand-alone use with an optional external medical grade, isolated power supply. It is used to provide topical heating for: Temporary increases in local blood flow and circulation. Temporary relief of minor muscle and joint aches Temporary relief of pain and stiffness Relaxation of muscles. Temporary relief (or relaxation) of muscle spasms. Temporary relief of minor pain and stiffness associated with arthritis

The HF54 Combination Ultrasound Interferential and Premodulated Stimulation System with optional hands-free operation is a device that provides ultrasonic diathermy, interferential current therapy, and infrared lamp therapy. It can be used with one or two ultrasound applicators, and the ultrasound therapy can be applied in a scanned or hands-free manner. An optional infrared light probe is also available.

The HF54 is indicated for: Pain relief for: Symptomatic relief of chronic intractable pain and/or management of traumatic or post surgical pain. Ultrasound therapy is available from the HF54 and indicated for: Applying therapeutic deep heat within body tissues for the treatment of selected chronic and sub-chronic medical conditions such as: Relief of pain Muscle Spasms Joint contractures The combination ultrasound & electrotherapy modes offer deep heat for pain management (ultrasound therapy) at the same time that electrical stimulation for either pain management or muscle stimulation is being delivered. Two electrotherapy modes utilizing Premodulated IFC can be utilized at a time in conjunction with the ultrasound mode. These are using One or two ultrasound applicators. The second ultrasound applicator is optional. An Infrared Therapy Probe is available as an optional accessory (HF023) for use with the Hill Laboratories HF54 Combination Ultrasound Interferential and premodulated stimulation system or for stand-alone use with an optional external medical grade, isolated power supply. It is used to provide topical heating for: . Temporary increases in local blood flow and circulation . Temporary relief of minor muscle and joint aches Temporary relief of pain and stiffness Relaxation of muscles . Temporary relief (or relaxation) of muscle spasms . Temporary relief of minor pain and stiffness associated with arthritis

The HF54 Combination Ultrasound Interferential and Premodulated Stimulation System is a device that offers electrical stimulation, ultrasonic therapy and/or combination of the two. It also has an optional Infrared light probe accessory (HF023).

The Air-Flex is a multi-function physical therapy table intended for medical purposes that consists of a motorized table which can be equipped to provide patients with powered distraction, powered flexion and muscle relaxation therapy.

The AIR-FLEX with AUTO-DISTRACTION is a modification of the AIR-FLEX table originally cleared under K932810 on 02/17/1995. This new platform will replace the model originally cleared under K932810. The device is a Hi-Lo multi-function physical therapy table as defined under 21 CFR 890.5880. Neither the proposed device nor the predicate device provides heat. The proposed device differs from the predicate device in that it utilizes precision pneumatic actuators for distraction force and positioning rather than electric motors that were used on the predicate. The height adjustment of the proposed device is performed using the same electric motor as the predicate. The proposed device has a new, optional automatic cycling mode intended to provide intermittent distraction and flexion. Additionally, the AIR-FLEX with AUTO-DISTRACTION can be configured with up to four pneumatically dropped sections including cervical (straight down and forward motion), thoracic, lumbar and pelvic. Each drop is activated by pressing a clearly marked button and is executed via a foot pedal. An Air-thoracic Breakaway (with release) allows for a thoracic recoil movement and features an adjustable air tension spring controlled by a foot pedal allowing the spring to lock at any point down to 5.5 inches. This allows the use of the table with patients with large abdominal areas. The Air-Breakaway can be combined with thoracic and lumbar drop. The proposed device can be fitted with an elevation headpiece. This raises up to 5 inches and is fitted with a tilting section. Manual or Air-activated drops can be added as options. The activation of the selected drop can be made by footswitches or optional cocking foot strips. The AIR-FLEX with AUTO-DISTRACTION table is configured to match the owner's preferences. The optional Auto-Flex allows the therapist to treat patients manually (for which the AIR-FLEX table is already cleared) or easily switch to AUTO-FLEX for motorized flexion. The stroke (controls the amount of flexion) can be adjusted. The patient lies prone on the treatment surface and the patent is secured around the waist using a seat-belt type strap with quick release buckle to the stationary part of the table. The ankles are secured using straps to the movable part of the table. Once the therapist is sure that the patient is properly secured, the therapist unlocks the movable section and sets the distraction force, which is read on a gauge on the table. The therapist has the option to perform manual cycling and, where the table is configured with the automatic cycling module, can now set the overall treatment time, relax level, the rate to increase, time to hold (Pull Time) and the time to rest (Rest Time).

The Healthstar Elite machine administers genuine intervertebral decompression. Each treatment session consists of a physician prescribed treatment period on the Healthstar Elite. A treatment is designed to provide static, intermittent, and cycling distraction forces to relieve pressures on structures that may be causing low back pain. The machine can be used to relieve sciatica pain and pain associated with: bulging or herniated discs, degenerative disc disease, and posterior facet syndrome. It achieves these effects through decompression of intervertebral discs, that is, unloading due to distraction and positioning. This device is for prescription use only.

The Healthstar Elite is a multifunction elevation table designed to apply distraction forces to a patient's spine. The powered elevation adjustments of the table's surface height are designed to provide easier loading and unloading of the patient on and off the table. The patient lies in a supine position on the table with either the knees bent or legs supported on an adjustable height stool creating a 90-degree bend between the calves and hamstrings. This position helps to provide comfort during distraction and to provide relaxation to the Para spine tissue during distraction. The upper body is restrained through a chest harness, which is attached underneath the rib cage. The harness is attached to a metal spreader bar and web strap, then attached through a cam-type buckle assembly. The lower body is restrained to the moveable lower section of the table through a flexible pelvic restraint is fixed to the table's lower moveable section. Each side of the restraint can be moved in and out width wise by pushing a lever and having a stud engage into one of three numbered holes, depending on the size of the patient. The flexible restraint is designed to capture and secure the patients iliac crest. The Healthstar Elite consists of two components: - 1. The elevation table with traction capabilities. - 2. An attachable control panel, which can be inserted into either side of the table. The elevation table is controlled by a 24-volt actuator and is elevated by pushing a hand control with built in arrows indications (no label required). The control panel allows the operator to select one of eight predetermined programs of distraction, time of treatment, pounds of distraction, and pelvic tilt angle.