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(1) When using Electrical Muscle Stimulation (NMES), Revitive is intended: · for users with conditions or diseases that are associated with impaired (poor) blood flow in the legs/ankles/feet, NMES though the foot-pads is intended for use as an adjunctive treatment (as an addition to your existing treatment) to temporarily reduce lower extremity pain, swelling and cramping - · to temporarily increase local blood circulation in healthy leg muscles - · to stimulate healthy muscles in order to improve and facilitate muscle performance - · to temporarily relieves pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arms) and lower extremities legs) due to strain from exercise or normal household duties - · for relaxation of muscle spasm, - · for increase of blood flow circulation. - · for prevention or retardation of disuse atrophy, - · for muscle re-education, - · for maintaining or increasing range of motion, and - · Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis - · Provide quadricep strengthening - · Improve knee stability secondary to quadricep strengthening (2) When using Revitive to deliver Transcutaneous Electrical Nerve Stimulation (TENS), it is intended to provide: - · symptomatic relief and management of chronic, intractable pain - · relief of pain associated with arthritis · temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arms) and lower extremities (legs) due to strain from exercise or normal household activities.

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NMES: - To temporarily increase local blood circulation in healthy leg muscles - To stimulate healthy muscles in order to improve and facilitate muscle performance. - For temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arms) and lower extremities (legs) due to strain from exercise or normal household duties - For relaxation of muscle spasm. - Increase of blood flow circulation, - Prevention or retardation of disuse atrophy, - Muscle re-education. - Maintaining or increasing range of motion, - Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis - For users with conditions or diseases that are associated with impaired (poor) blood flow in the legs/ankles/feet, NMES through the foot-pads is intended for use as an adjunctive treatment (as an addition to your existing treatment) to temporarily reduce lower extremity pain, swelling and cramping TENS: - For symptomatic relief and management of chronic intractable pain - Relief of pain associated with arthritis - For temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arms) and lower extremities (legs) due to strain from exercise or normal household activities

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NMES: - To temporarily increase local blood circulation in healthy leg muscles - To stimulate healthy muscles in order to improve and facilitate muscle performance. - For temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities - (arms) and lower extremities (legs) due to strain from exercise or normal household duties - For relaxation of muscle spasm, - Increase of blood flow circulation, - Prevention or retardation of disuse atrophy, - Muscle re-education, - Maintaining or increasing range of motion, and - Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis TENS: - For symptomatic relief and management of chronic intractable pain - Relief of pain associated with arthritis - For temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arms) and lower extremities (legs) due to strain from exercise or normal household activities

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· To temporarily increase local blood circulation in healthy leg muscles · To stimulate healthy muscles in order to improve and facilitate muscle performance. · For temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arms) and lower extremities (legs) due to strain from exercise or normal household duties.

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The Revitive IX (OTC) is intended to be used for electrical stimulation of the muscles of the lower leg for the purposes of supporting muscle function, and improving blood circulation. In addition Revitive IX (OTC) is intended to be used for electrical stimulation of sore and aching muscles to relieve pain. The device is intended for home use for 30 minutes per treatment with a maximum of 3 hours treatment time per day as required. Revitive IX (OTC) is indicated for: - To temporarily increase local blood circulation in healthy leg muscles - To stimulate healthy muscles in order to improve and facilitate muscle performance. ● - For temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arms) and lower extremities (legs) due to strain from exercise or normal household duties.

The Revitive IX (OTC) consists of foot pads and/or electrode pads that deliver electrical stimulation to the lower limb muscles, electrode pads may also deliver electrical stimulation to muscles in the shoulder, waist, back and arms; an optional feature that allows for ankle movement during stimulation; a remote control; dust protectors for the electrode pads; and a user interface. Replacement electrode pads are available separately under 510(k) K132588. Revitive IX (OTC) is a neuromuscular electrical stimulation (NMES) device that applies electrical impulses that are of sufficient intensity to produce an artificial contraction of the muscle tissue. The device delivers electrical stimulation to the lower limb muscles through foot pads and/or through electrode pads which may be positioned on the lower limb, waist, back or arms. The foot pads are made of conductive black nitrile butyl rubber (NBR) containing carbon, while the electrode pads are made from conductive carbon film coated with an adhesive hydrogel on a cloth backing. It has an optional IsoRocker™ feature that allows ankle movement during stimulation. When enabled, the lsoRocker™ allows Revitive IX (OTC) to tilt back and forth as the muscles contract and relax. The main body of the device is constructed from ABS plastic. The Revitive IX (OTC) is intended for multiple uses in the home environment and is not provided sterile. The software included in the device controls the pulses generated by the device to stimulate the muscle. The software allows the device to generate various different shapes of pulses with different repetition rates, duration and magnitude. The Revitive IX (OTC) utilizes standard household AC/DC power supply with a 5V DC power adaptor.