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The Neurological Theray Devices - Accessories including Garment electrodes which are intended to be used with legally marketed electrical stimulating devices such as transcutaneous electrical nerve stimulators or powered muscle stimulators. The cutaneous electrodes will deliver the stimulation signals generated by the stimulator to the body surface with which they are in contact. The Garment electrodes including glove, socks, sleeve, knee belt and back belt which are made up of silver or conductive silicone rubber.

The Neurological Therapy Devices - Accessories -Conductive fiber(Model:Electrotherapy device Electrode for Knee, Electrotherapy device Electrode for Elbow, Electrotherapy device Electrotherapy device Electrode socks.Neurological physiotherapy devices-accessories), are conductive garments that are made from material which is knitted from primarily nylon yarn with minor amounts of lycra, spandex to achieve a stretch fabric for a snug garment fit polyester for tactile qualities and polyester sheathed carbon yarn and pure silver coated nylon fibers to provide conductivity. The knitting follows standard knitting procedures with the conductive knitted material being fabricated into Neurological Therapy Devices - Accessories garments which are provided in multiple sizes of various garment configurations including; gloves, bands, socks, and sleeves. The Neurological Therapy Devices - Accessories-conductive silicone rubber(Model:Electrotherapy device Electrode belt for back of body, Electrotherapy device Electrode belt for Abdominal Muscle TrainerToning, Electrotherapy device Electrode belt for Body joints,Electrotherapy device Electrode belt for arm of body,Electrotherapy device Electrode belt for back of body,Electrotherapy device Electrode belt for shoulder of body,Neurological physiotherapy devices-accessories), is made of conductive silicone rubber coated in conductive garments material, has excellent conductive performance and good flexibility and plasticity, can adapt to the needs of different shapes and sizes of electrodes. The stretch characteristics of the material provide sufficient elasticity to ensure firm surface contact with the skin. The design of the devices is such that they can be used skin by reversing the surface contacting the skin. The Neurological Therapy Devices - Accessories utilize conductive silicone rubber as a conduit for current transmission. When current passes through the garment electrodes, the conductive silicone rubber transmit the current to the surface of the body, thus enabling the transmission of current. The entire surface of the Neurological Therapy Devices - Accessories is very conductive having a resistance of less than 7 ohms per inch. This provides low current density with uniform current distribution to enable efficient use of these Neurological Therapy Devices - Accessories for use in TENS (transcutaneous electrical nerve stimulators) and NMES (powered muscle stimulator devices). The Neurological Therapy Devices - Accessories are non- sterile external devices which are designed for single patient, for multiple uses and are intended for Prescription Use and/or OTC use with FDA Cleared TENS and NMES class II devices.

Model:R-C101W: - For TENS/IF/MIC mode - 1. Symptomatic relief of chronic intractable pain - 2. Post traumatic pain - 3. Post surgical pain - For EMS/RUSS mode - 1. Relaxation of muscle spasm. - 2. Increase of local blood flow circulation - 3. Prevention or retardation of disuse atrophy - 4. Muscle re-education - 5. Maintaining or increasing range of motion. - 6. Immediate post-surgical stimulation of muscles to prevent venous thrombosis Model:R-C101A - For TENS/IF mode - 1) Symptomatic relief of chronic intractable pain. - 2) Post traumatic pain. - 3) Post surgical pain. - For EMS/RUSS mode - 1) Relaxation of muscle spasm. - 2) Increase of blood flow circulation. - 3) Prevention or retardation of disuse atrophy. - 4) Muscle re-education. - 5) Maintaining or increasing range of motion. - 6) Immediate post-surgical stimulation of muscles to prevent venous thrombosis Model:R-C101B For TENS/IF mode - 1. Symptomatic relief of chronic intractable pain - 2. Post traumatic pain - 3. Post surgical pain - For EMS/RUSS mode - 1. Relaxation of muscle spasm. - 2. Increase of local blood flow circulation - 3. Prevention or retardation of disuse atrophy - 4. Muscle re-education - 5. Maintaining or increasing range of motion. - 6. Immediate post-surgical stimulation of muscles to prevent venous thrombosis Model:R-C101E For IF mode - 1. Symptomatic relief of chronic intractable pain - 2. Post traumatic pain - 3. Post surgical pain For RUSS mode - 1. Relaxation of muscle spasm. - 2. Increase of local blood flow circulation - 3. Prevention or retardation of disuse atrophy - 4. Muscle re-education - 5. Maintaining or increasing range of motion. - 6. Immediate post-surgical stimulation of muscles to prevent venous thrombosis Model:R-C101H For TENS and IF mode - 1) Symptomatic relief of chronic intractable pain. - 2) Post traumatic pain. - 3) Post surgical pain. Model:R-C101D For TENS mode - 1. Symptomatic relief of chronic intractable pain - 2. Post traumatic pain - 3. Post surgical pain Model:R-C101G For TENS mode - 1) Symptomatic relief of chronic intractable pain. - 2) Post traumatic pain. - 3) Post surgical pain. For EMS mode - 1. Relaxation of muscle spasm. - 2. Increase of local blood flow circulation - 3. Prevention or retardation of disuse atrophy - 4. Muscle re-education - 5. Maintaining or increasing range of motion. 6. Immediate post-surgical stimulation of muscles to prevent venous thrombosis

The Combo Electrotherapy Device (Models: R-C101W, R-C101B, R-C101E, R-C101H, R-C101D, and R-C101G) is a Transcutaneous Electrical Nerve Stimulator. The device features two independent output channels and four selfadhesive electrode gel pads. The stimulator sends a gentle electrical current to the underlying nerves and muscle groups via electrodes applied on the skin. Users can choose from pre-set programs or specify their own to suit their individual needs. All controls and indicators are controlled by software which also controls waveform characteristics. The 7 models have similar housing with a viewable LCD display and an accessible keypad. The LCD is located on the upper half of the rectangular face of the device above the keypad. It is used to display system information to the user. The device is battery-powered but can be connected to an external power supply its internal battery which is a non-user serviceable or accessible 3.7V D.C., Li-ion battery. There are only two external connections on the device - power input and electrode connector - with no connection to any other devices. The Battery Charger is not included in the package; however, users can choose adapters that meet IEC 60601-1 medical stardards.

Self-Adhesive Electrode is intended for use as a reusable, conductive adhesive interface between the patient's skin and the marketed electrical stimulators (i.e.TENS (Transcutaneous Electrical Nerve Stimulation), EMS (Electrical Muscular Stimulation), IF or IFC(Interferential current) or PGF (Pulsed Galvanic Stimulation) for transmitting electrical current, for OTC (Over-The-Counter) or Prescription use.

Self-Adhesive Electrode are composed of conductive carbon film and adhesive Electrodes composed of Aluminum foil film,Adhesive Electrodes manufactured by Roundwhale are multi-layer reusable, flexible structures composed of laminated materials commonly used in this application: 1. Top layer: Fabric/Foam/ Tan fabric 2. Middle layer: Conductive film (Silver coated Carbon Film/Carbon film/Aluminum foil film) 3. Bottom layer: Biocompatible self-adhesive conductive hydrogel 4. Connection: Leadwire/snap button/magnetic button 5. double sides adhesive tape: Which is used for attaching the non-woven fabrics and conducting film 6. Release film: Release film is a protective layer for the hydrogel. The electrodes are designed for single-patient/multiple application use. Because of the adhesive nature of the biocompatible conductive hydrogel, no securing materials are required to secure the device to the patient's skin. For the electrical connection, Roundwhale provides lead wire type and snap button/Magnetic button type: - Leadwire assembly: The electrode is connected to the electrical stimulator by lead wire, at least 40 mm long wire with a standard connector: 0.08"/0.1"(2mm/2.5mm) diameter female socket connector with insulating outer. - Snap button/Magnetic button assembly: With 2.5~5mm diameter male socket.

Over-The-Counter Use: TENS mode:: It is used for temporary relief of pain associated with sore and aching muscles in the neck, shoulder, back, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities. EMS mode: This mode is designed to be used for stimulate healthy muscles in order to improve and facilitate muscle performance. Prescription Use: For TENS mode: - 1) Symptomatic relief of chronic intractable pain: - 2) Post traumatic pain: 3) Post surgical pain; For EMS mode: - 1) Relaxation of muscle spasm; - 2) Increase of local blood flow circulation; - 3) Prevention or retardation of disuse atrophy; - 4) Muscle re-education; - 5) Maintaining or increasing range of motion; - 6) Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.

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R-C1 TENS and EMS Stimulator For TENS mode: - 1. Symptomatic relief of chronic intractable pain; - 2. Post traumatic pain; - 3. Post surgical pain; For EMS mode: - 1. Relaxation of muscle spasm; - 2. Increase of local blood flow circulation; - 3. Prevention or retardation of disuse atrophy; - 4. Muscle re-education; - 5. Maintaining or increasing range of motion; - 6. Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis. - R-E1 EMS Stimulator - 1. Relaxation of muscle spasm; - 2. Increase of local blood flow circulation; - 3. Prevention or retardation of disuse atrophy; - 4. Muscle re-education; - 5. Maintaining or increasing range of motion; - 6. Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis. - R-T1 TENS Stimulator - 1. Symptomatic relief of chronic intractable pain; - 2. Post traumatic pain; - 3. Post surgical pain.

The RW Series A Electrical Stimulator, which includes models R-C1, R-E1 and R-T1, are Transcutaneous Electrical Nerve Stimulator and muscle stimulator for pain relief and/or Electrical Muscle Stimulator sends gentle electrical current to underlying nerves and muscle group via electrodes applied on the skin. The parameters of units are controlled by the press buttons. Its intensity level is adjustable according to the needs of patients. The device unit of R-C1 was portable device, battery powered (6.0V DC) multi-function device offering both Transcutaneous Electrical Nerve Stimulator(TENS) and Powered Muscle Stimulator (EMS) qualities in one device. The stimulator is used with electrodes. For the electrodes are provided by the manufacturer Top-Rank Health Care Equipment Co. Ltd, cleared under K070612. The three models of R-C1, R-E1 and R-T1 have the same appearance, structure, display, electrical principle and critical components, the main differences are software and color. The R-C1 have TENS mode (12 programs), EMS mode (9 programs). The R-E1 only have EMS mode (9 programs) and R-T1 only have TENS mode (12 programs). The R-C1 was combination the function of R-E1 and R-T1.

R-C1 TENS and EMS Stimulator TENS: This mode is designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities. EMS: This mode is designed to be used for stimulate healthy muscles in order to improve and facilitate muscle performance. R-E1 EMS Stimulator This device is designed to be used for stimulate healthy muscles in order to improve and facilitate muscle performance. R-T1 TENS Stimulator This device is designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities.

The RW Series A Electrical Stimulators, which includes models R-C1 TENS and EMS stimulator, R-E1 EMS stimulator and R-T1 TENS stimulator, are Transcutaneous Electrical Nerve Stimulator and muscle stimulator for pain relief and/or Electrical Muscle Stimulator. The stimulator sends gentle electrical current to underlying nerves and muscle group via electrodes applied on the skin. The parameters of units are controlled by the press buttons. Its intensity level is adjustable according to the needs of patients. The device unit of R-C1 was portable device, battery powered (6.0V DC) multi-function device offering both Transcutaneous Electrical Nerve Stimulator(TENS) and Powered Muscle Stimulator (EMS) qualities in one device. The electrode size is 50*50mm, the manufacturer is Top-Rank Health care Equipment Co., Ltd. The electrode is OTC use and cleared with 510(K), the cleared number is K132588. It has been evaluated and tested according to ISO 10993-1/-5 and -10 standards. The three models of R-C1, R-E1 and R-T1 have the same appearance, structure, display, electrical principle and CDF, the main differences are software and color. The R-C1 have TENS mode (18 programs), EMS mode (15 programs). The R-E1 only have EMS mode (15 programs) and R-T1 only have TENS mode (18 programs). The R-C1 was combination the function of R-E1 and R-T1.