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510(k) Data Aggregation

    K Number
    K031884
    Device Name
    INTERFERENTIAL STIMULATOR, MODEL NETWAVE
    Manufacturer
    RYAN TELEMEDICINE
    Date Cleared
    2003-06-30

    (12 days)

    Product Code
    IPF
    Regulation Number
    890.5850
    Why did this record match?
    Applicant Name (Manufacturer) :

    RYAN TELEMEDICINE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    netwaye Interferential Stimulator is a multifunction device intended to be used for muscle and nerve stimulation using either of its two therapy modes, Interferential Current Stimulation or Neuromuscular Electrical Stimulation. In the Interferential Current Mode, netwave is indicated for the following conditions: - . Symptomatic relief of acute pain - Symptomatic management and relief of chronic pain - . Adjunctive treatment for the management of post traumatic and Post-surgical pain In the Neuromuscular Stimulation Mode, netwave is indicated for the following conditions: - Relaxation of muscle spasms; - Prevention or retardation of disuse atrophy; - Increasing local blood circulation; - Muscle re-education; - Immediate post surgical stimulation of calf muscles to prevent venous thrombosis; and - Maintaining or increasing range of motion.
    Device Description
    The Ryan Telemedicine netwave Interferential Stimulator is a battery powered (rechargeable) device intended for clinic, and outpatient use. Prescribed by a physician, netwave gives the clinician a variety of electrotherapy modes to treat a range of indications. netwaye is designed for clinician and patient ease of use and provides safe and effective dispensing of the desired electrotherapy treatment. netwave incorporates the following features: - independent stimulation channels, which provide true ● Two interferential current and neuromuscular stimulation. - Continuous or pulsed stimulation. Adjustable sweep and ramp times. ● - . Adiustable amplitude and frequency - Four programmable therapy protocols - . Five preset therapy protocols - . Adjustable on and off times - Pause button to allow temporary cessation of treatment and a . resume button to allow the continuance of treatment. When a treatment session is paused, the timer does not countdown. Upon resumption of treatment, the timer resumes its countdown and the amplitude (intensity) is reset to zero. - Easy to connect, easy to handle, patient lead wire/cable assembly . with a "one way" connector and color coded lead wires contribute to improved patient experience and improved therapy outcomes. - . Timed therapy sessions. - . Robust rechargeable Nickel Metal Hydride battery system with rapid recharge (85% recharge in 30 minutes - full charge in 2 hours) - . Charging / communicating cradle which serves as "home base" for netwave and provides a simple recharging system for the user/patient. The use of the charging cradle ensures netwave is always at peak battery power. - The communication functions of the cradle allow for the uploading of patient data (compliant with HIPAA requlations) to an Internet data server for use by the patient's authorized caregivers. NO INDIVIDUALLY IDENTIFIABLE PATIENT DATA is transmitted. - netwave user interface incorporates a touch screen Liquid Crystal Display (LCD) as the main device/user interface.
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    K Number
    K030254
    Device Name
    INTERFERENTIAL STIMULATOR, MODEL RTM1000
    Manufacturer
    RYAN TELEMEDICINE
    Date Cleared
    2003-02-26

    (33 days)

    Product Code
    IPF, LIH
    Regulation Number
    890.5850
    Why did this record match?
    Applicant Name (Manufacturer) :

    RYAN TELEMEDICINE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The RTM1000 Electrotherapy Device is a multifunction device intended to be used for muscle and nerve stimulation using either of its two therapy modes, Interferential Current Stimulation and Neuromuscular Electrical Stimulation. In the Interferential Current Mode the RTM1000 is indicated for the following conditions: - . Symptomatic relief of acute pain - . Symptomatic management and relief of chronic pain - . Adjunctive treatment for the management of post traumatic and Post-surgical pain In the Neuromuscular Stimulation Mode, the RTM1000 is indicated for the following conditions: - . Relaxation of muscle spasms; - . Prevention or retardation of disuse atrophy; - Increasing local blood circulation; - . Muscle re-education; - . Immediate post surgical stimulation of calf muscles to prevent venous thrombosis: and - Maintaining or increasing range of motion.
    Device Description
    The Rvan Telemedicine RTM1000 Interferential Stimulator is a battery powered (rechargeable) device intended for clinic, and outpatient use. Once prescribed by a physician it gives the clinician a variety of electrotherapy modes to treat a range of indications. The RTM1000 is designed for clinician and patient ease of use and provides safe and effective dispensing of the desired electrotherapy treatment. The RTM1000 incorporates the following features: - . Two independent stimulation channels, which provide true interferential current, neuromuscular stimulation and transcutaneous electrical nerve stimulation. - . Continuous or pulsed stimulation. Adjustable sweep and ramp times. - . Adjustable amplitude and frequency - . Four programmable therapy protocols - . Five preset therapy protocols - . Adjustable on and off times - . Pause button to allow temporary cessation of treatment and a resume button to allow the continuance of treatment. When a treatment session is paused, the timer does not countdown. Upon resumption of treatment, the timer resumes it's countdown and the amplitude (intensity) is reset to zero. - . Easy to connect, easy to handle, patient lead wire/cable assembly with a "one way" connector and color coded lead wires contribute to improved patient experience and improved therapy outcomes. - . Timed therapy sessions. Robust rechargeable Nickel Metal Hydride battery system with . rapid recharge (85% recharge in 30 minutes - full charge in 2 hours)
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