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Apply stationary use of ultrasound to: Generate deep heat within body tissues for the treatment of selected medical conditions such as the relief of pain, the relief of muscle spasms, the treatment of joint contractures, and the local increase in circulation. Apply continuous movement of ultrasound for: 1. Pain. 2. Pain relief, muscle spasms, and joint contractures. 3. Relief of pain, muscle spasms, and joint contractures that may be associated with: - Adhesive capsulitis, - Bursitis with slight calcification, - Myositis, - Soft tissue injuries, and - Shortened tendons due to past injuries and scar tissues. 4. Relief of pain, muscle spasms, and joint contractures resulting from: - Capsular tightness, and - Capsular scarring. 5. Localized increase in blood flow. 6. Increased range of motion of contracted joint using heat and stretch techniques.

As a portable and rechargeable prescriptive device in the home or clinical/hospital setting, the subject device is intended to apply ultrasound to the patient's treatment site. It is demonstrated ultrasound can be used to apply therapeutic deep heat for the treatment of medical conditions including relief of pain, muscle spasms, and joint contractures. It is intended to be used for 30 minutes per cycle (up to 4 cycles) in the home or clinical/hospital setting by or under the direction of a medical professional to apply ultrasound to the patient's treatment site. The device automatically alerts the patient in case of improper application or performance. All the control components and the rechargeable battery of the device are protectively housed, and the device is connected to one or two applicators of ultrasound. The subject device consists of the main device, the applicator, the charger/adapter, the liquid and/or solid ultrasound gel, and the sticky pad. For the best result, use the ultrasound gel and the sticky pad supplied.

Therapeutic Ultrasound is indicated for: • Pain Relief • Reduction of muscle spasms • Localized increase in blood flow • Increase range of motion of contracted joints using heat and stretch techniques

This device is a multi-frequency ultrasound therapy equipment. The mounted applicators provide both 1 and 3 MHz operation. Depending on the area of treatment, two different types of applicators, large and small, are available. They are suitable for treatment under water. Contact control suspends the application of ultrasound energy when acoustical contact with the treatment area becomes insufficient. The user can connect two ultrasound applicators. Activation of each applicator can be controlled from the ultrasound menu. This device is a prescription equipment. Use by any persons other than physicians is prohibited.

Apply stationary use of ultrasound to: Generate deep heat within body tissues for the treatment of selected medical conditions such as the relief of muscle spasms, the treatment of joint contractures, and the local increase in circulation. Apply continuous movement of ultrasound for: 1. Pain. - 2. Pain relief, muscle spasms, and joint contractures. - 3. Relief of pain, muscle spasms, and joint contractures that may be associated with: - · Adhesive capsulitis, - · Bursitis with slight calcification, - · Myositis, - · Soft tissue injuries, and - · Shortened tendons due to past injuries and scar tissues. - 4. Relief of pain, muscle spasms, and joint contractures resulting from: - · Capsular tightness, and - · Capsular scarring. - 5. Localized increase in blood flow. - 6. Increased range of motion of contracted joint using heat and stretch techniques.

The ManaSport+ is an adaptation of the previously cleared ManaSport device, which was cleared under K210284. A wireless control option was added to the ManaSport+ and the subject device was evaluated for home use. As a portable and rechargeable prescriptive device in the home or clinical/hospital setting, the subject device is intended to apply ultrasound to the patient's treatment site for selected medical conditions such as the relief of pain, the relief of muscle spasms, the treatment of joint contractures, and the local increase in circulation. Ultrasound can be used to apply therapeutic deep heat for the treatment of selected medical conditions such as soft tissue injuries, shortened tendons due to past injuries and scar tissues, relief of pain, muscle spasms and joint contractures.

Apply stationary use of ultrasound to: Generate deep heat within body tissues for the treatment of selected medical conditions such as the relief of muscle spasms, the treatment of joint contractures, and the local increase in circulation. Apply continuous movement of ultrasound for: 1. Pain. - 2. Pain relief, muscle spasms, and joint contractures. - 3. Relief of pain, muscle spasms, and joint contractures that may be associated with: - · Adhesive capsulitis. - · Bursitis with slight calcification, - · Myositis, - · Soft tissue injuries, and - · Shortened tendons due to past injuries and scar tissues. - 4. Relief of pain, muscle spasms, and joint contractures resulting from: - · Capsular tightness, and - · Capsular scarring. - 5. Localized increase in blood flow. - 6. Increased range of motion of contracted joint using heat and stretch techniques.

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Therapeutic Ultrasound - Pain relief - Reduction of muscle spasms - Localized increase in blood flow - Increase range of motion of contracted joints using heat and stretch techniques

The SONOMED apparatus is ultrasound equipment for therapy, which has been developed in accordance with the safety standards IEC 60601-2 and IEC 60601-2 and IEC 60601-2-5, class II, type BF, which makes it a safe apparatus of high reliability for the therapist and the patient. SONOMED is medical electric equipment which provides therapeutic ultrasound treatment. Ultrasound is a mechanic stimulus directed to the body through ultrasonic beam emitted by a transducer/applicator, better known as head. This ultrasound is produced in the head through a piezoelectric crystal and is transmitted to the body through the aluminum surface of the head and a contact agent (gel). Depending on how the ultrasound beam passes through the tissues, its energy is gradually and selectively absorbed being transformed into heat, among other effects. This increase in temperature causes biological changes in the tissues as for instance increase in micro circulation, a reduced perception of pain, a reduction in inflammatory activity and an increase in the reestablishing rate of delicate tissues. The higher the ultrasound frequency, the more superficial will be its absorption.

Therapeutic Ultrasound: 1. Pain relief 2. Reduction of muscle spasm 3. Localized increase of blood flow 4. Increase range of motion of contracted joints using heat and stretch techniques. Neuromuscular Stimulation: 1. Symptomatic relief of chronic intractable pain, acute post traumatic pain or acute surgical pain 2. Temporary relaxation of muscle spasm 3. Prevention of post-surgical phlebo-thrombosis through immediate stimulation of calf muscles 4. Increase of blood flow in the treatment area. 5. Prevention or retardation of disuse atrophy in post-injury type conditions 6. Muscle re-education 7. Maintaining or increasing range of motion

The BRH-A2 CUSEFS is comprised of the following main components: - A system console including software and control electrodes; ● - A control and display panel - Specially designed cart - User-friendly touch screen . The BRH-A2 CUSEFS is powered by standard one phase 120 or 230 V power supply. The BRH-A2 CUSEFS is a two-channel combination unit for therapeutic ultrasound and 4-Pole Interferential Current therapy folded into a specially designed cart. The microprocessor controlled BRH-A2 CUSEFS provides 4-Pole Interferential Current therapy alternating current with enhanced reliability and user friendly interface. The BRH-A2 CUSEFS offer 1 and 3 MHz ultrasound treatment modes. There is a user-friendly touch screen interface. The screen provides operator information about operation mode and signal intersities. Large control knobs on the touch screen make adjusting power for ultrasound and muscle stimulation. The BRH-A2 CUSEFS can provide 4-Pole Interferential Current therapy only and ultrasound treatment only.

Application of therapeutic ultrasound for: · Pain. - · Pain relief, muscle spasms, and joint contractures. - · Relief of pain, muscle spasms, and joint contractures that may be associated with: - o Adhesive capsulitis. - o Bursitis with slight calcification, - o Myositis, - o Soft tissue injuries, and - o Shortened tendons due to past injuries and scar tissues. - · Relief of pain, muscle spasms, and joint contractures resulting from: - o Capsular tightness, and - o Capsular scarring. - · Localized increase in blood flow. - · Increased range of motion of contracted joints using heat and stretch techniques.

The JAS Pulse is a physical medicine ultrasonic diathermy device. The JAS Pulse device consists of a handheld transducer that generates high frequency sound waves. These sound waves penetrate tissue and are used to treat injured or painful areas of the body in order to alleviate symptoms and to stimulate blood flow. The handheld device is intended to be single patient use and is used with ultrasonic gels to facilitate coupling to the patient's skin surface and to enhance ultrasonic penetration. Components of the JAS Pulse device include the handheld electrical control unit with user interface to select treatment power levels and time intervals. The controller drives the handheld treatment applicator to provide continuous and pulsed 1MHz therapeutic ultrasound. Ultrasonic gels applied to the user's area of pain facilitate ultrasonic coupling and penetration to facilitate the therapeutic ultrasound.

The Modified Alma Lasers Family of Accent RF Systems [Accent XL, Accent Elite] is intended for use in dermatological and general surgical procedures. The Alma Lasers Family of Accent RF Systems [Accent XL, Accent Elite] is indicated for the non-invasive treatment of wrinkles and rhytids using a combined treatment with Unipolar and Bipolar hand pieces. The massage component of the Alma Lasers Accent Uniform Hand piece is intended for use with the Modified Alma Lasers Family of Accent RF Systems [Accent, Accent XL, Accent Elite] to provide: -Temporary reduction in the appearance of cellulite. Simultaneous application of the RF energy and mechanical manipulation of the skin is intended for use with the Modified Alma Lasers Family of Accent RF Systems [Accent, Accent XL, Accent Elite] to provide: -Temporary reduction in the appearance of cellulite. The Unipolar and Bipolar hand pieces, when used as a combined treatment, are indicated for the non-invasive treatment of wrinkles and rhytids. The Pixel RF Tips (stationary and rolling), when used with the unipolar hand piece, are indicated for dermatological procedures requiring ablation and resurfacing of the skin. Ultrasound Module provides ultrasonic diathermy intended for: - Relief of pain - Muscle spasms - · Joint contractures - · NOT for the treatment of malignancies The hand pieces above are intended to be used with the console cleared in K101147 Alma Lasers Family of Accent RF Systems [Accent, Accent XL, Accent Elite].

The Alma Lasers Accent XL is a console with three previously cleared RF hand pieces and one ultrasound hand piece that is the subject of this submission. The previously cleared hand pieces have not changed from what was cleared in their associated 510(k) submissions. The new ultrasound hand piece is a therapeutic ultrasound hand piece with a frequency of 1 MHz using a 1.2 cm transducer. The touch screen on the console shows the treatments that have been chosen and when the output is active.

The MC1 Plus is indicated for: a) Therapeutic Massager: 1. Provides temporary relief of minor muscle aches and pains; 2. Relieves muscle spasms; 3. Temporarily improves local blood circulation; 4. Temporarily reduces the appearance of cellulite. b) Ultrasonic Diathermy: 1. Relief of pain; 2. Muscle spasms; 3. Joint contractures; 4. NOT for the treatment of malignancies.

MC1 Plus is a computerized body massager and ultrasound diathermy system. The MC1 Plus is supplied with two handpieces: one ultrasonic handpiece with two 1 MHz transducers mounted on it and one handpiece for computerized body massager.

Therapeutic Ultrasound: 1) Pain relief; 2) Reduction of muscle spasm; 3) Joint contractures: 4) Localized increase in blood flow. Transcutaneous Electrical Nerve Stimulation: 1) Symptomatic relief of chronic intractable pain 2)Post-traumatic pain 3)Post-surgical pain

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