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    K Number
    K223151
    Device Name
    Nu-beca Transcutaneous Electrical Nerve Stimulation
    Manufacturer
    Nu-Beca & Maxcellent Co.
    Date Cleared
    2023-07-19

    (287 days)

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

    **Nu-Beca **& Maxcellent Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The nu-beca Transcutaneous Electrical Nerve Stimulation is indicated for temporary relief of pain associated with sore and aching muscles in the lower back and upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities.
    Device Description
    The nu-beca Transcutaneous Electrical Nerve Stimulation consists of following components and accessories: TENS Stimulator, Electrode Pad, nu-beca Gel Pad, Charging Cable, Storage Pad. The device releases electrical current with adjustable frequencies and voltages to temporarily relief sore and aching muscles. It has only one model: TN0001. The treatment time for one session use is 15 minutes.
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