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510(k) Data Aggregation

    K Number
    K965187
    Device Name
    SPECTRUM II, SPECTRUM PLUS, AND SPECTRUM MAX-SD
    Manufacturer
    SPARTA SURGICAL CORP.
    Date Cleared
    1997-08-01

    (220 days)

    Product Code
    GZJ84G
    Regulation Number
    882.5890
    Why did this record match?
    Applicant Name (Manufacturer) :

    SPARTA SURGICAL CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    For symptomatic relief and management of chronic pain and as an adjunctive treatment in the management of post-surgical and post-traumatic acute pain.
    Device Description
    Spectrum II, Spectrum Plus, and Spectrum MAX-SD TENS devices
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