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510(k) Data Aggregation

    K Number
    K090866
    Device Name
    NEUROCALM MODEL 1 AND 2
    Date Cleared
    2009-10-21

    (204 days)

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

    NEUROMED DEVICES, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The NeuroCalm Transcutaneous Electrical Nerve Stimulator Device is indicated for symptomatic relief and management of chronic, intractable pain, and adjunctive treatment in the management of post-surgical and post-traumatic pain.
    Device Description
    The NeuroCalm device is a battery-powered portable TENS device intended for the relief of chronic intractable pain and adjunctive treatment of postsurgical or post-traumatic acute pain. The device is small, portable and lightweight. The device is available in two configurations: Model 1 and Model 2. The Model 1 configuration provides a 10-second treatment using a proprietary wave form while Model 2 provides a 35-second treatment using a slightly different waveform to alleviate pain. The NeuroCalm TENS device is powered by a 12-volt battery. The power source provides ample power for the 10-course treatment. The device has a two-year shelf life. Treatment is provided by passing AC and DC current through noble metal (gold) electrodes. Treatment cycles are controlled by software-controlled printed circuit board assemblies. Electrical output and waveforms are optimized depending on the treatment duration desired. A complete course of treatment consists of a 10 x 10-second treatment for Model 1 and a 10 x 35second treatment for Model 2. After the conclusion of the tenth treatment, the device is inoperable and may be discarded (discard as one would discard a battery).
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