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510(k) Data Aggregation

    K Number
    K212832
    Device Name
    TimeWaver Frequency
    Manufacturer
    TimeWaver Production GmbH
    Date Cleared
    2021-12-14

    (98 days)

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

    TimeWaver Production GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    As an NMES device, indications are for the following conditions: -Relaxation of muscle spasms -Retardation or prevention of disuse atrophy -Increased local blood circulation -Re-Educating muscles -Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis -Maintaining or increasing range of motion. As a TENS device, indications are for the following conditions: -Symptomatic relief and management of chronic intractable pain -Adjunctive treatment for post-surgical and post-traumatic acute pain
    Device Description
    TimeWaver Frequency is an electrical stimulation device that supports the treatment of specific medical conditions, using currents in the microampere range with different frequencies. It can be applied to different areas of the body and is a multifunctional electrotherapy device with two stimulation channels and two treatment modes that deliver neuromuscular electrical stimulation (NMES) and transcutaneous electrical nerve stimulations (TENS). The TimeWaver Frequency device is a prescription device intended to be used by healthcare providers in a healthcare setting and is not approved for use in a home environment. The use of the device on a particular patient is solely the decision of the medical professional, who is responsible for having the proper training and exercising his or her informed medical judgement. The principals of electrotherapy correspond to the process observed during voluntary muscle contraction. NMES pulses stimulate motor points of target muscle contraction. This can help reeducate and strengthen muscles following injury or surgery. TENS blocks the pain signal sent from the affected area on nerve pathways. The TimeWaver Frequency device provides 6 treatment programs for NEMS and two treatment programs for TENS. The NMES programs are for relaxation of muscle spasms, disuse atrophy, blood circulations, re-educating muscles, stimulation of calf muscles, and range of motion. The TENS programs are for chronic pain and acute pain. In all modes adhesive electrodes are used to deliver the stimulation. The TimeWaver Frequency is controlled by an application software program. A personal computer or a notebook is necessary to install the application software and is not provided with the TimeWaver Frequency system. The TimeWaver Frequency software must be used as a stand-alone application on its own computer, which is not used for other software applications. The user interface has several sections. The title bar contains the current program version, the lower status bar shows if hardware components are correctly connected, and the menu bar allows selection of the section to work within. The software requires setting up a new client to include relevant patient information. Treatments are conducted by selecting the appropriate treatment from the Programs module. The TimeWaver Frequency device operates using an external power supply and/or an internal battery. It is supplied with instructions for use, the TimeWaver Frequency device, power supply, USB cable, electrode connector cables, 50mm x 50mm and 50mm x 90 mm adhesive electrodes.
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    K Number
    K191075
    Device Name
    Healy
    Manufacturer
    TimeWaver Production GmbH
    Date Cleared
    2019-11-22

    (213 days)

    Product Code
    NUH, NYN
    Regulation Number
    882.5890
    Why did this record match?
    Applicant Name (Manufacturer) :

    TimeWaver Production GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, arms and legs due to strain from exercise or normal household work activities and for the symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.
    Device Description
    The Healy device is a single channel wearable electrotherapy device that is designed to alleviate temporary and chronic muscle and joint pain on multiple body locations. It delivers microcurrent therapy through the simple and convenient use of the dedicated iOS or Android App, or on product controls. Reusable, selfadhesive and contouring electrodes allow for discreet and convenient placement on multiple pain locations on the body. The system contains one unit, which is rechargeable and is attached to the electrode via cables. The electrode can then be applied to intact skin at the desired location for therapy and pain relief. Control of the Healy system is completed through the available App or on product controls.
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