LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K984376
    Device Name
    ENDOR 2000
    Manufacturer
    T.C. MEDICAL, INC.
    Date Cleared
    2000-06-07

    (548 days)

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

    T.C. MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Symptomatic relief and management of chronic (long-term) intractable pain and as an adjunctive treatment in the management of post surgical and post traumatic acute pain problems.
    Device Description
    Basic Design Description of submission compares the specifications of the ENDOR 2000 with a legally marketed product, the model 804S III (K893874B) sold by Altoona Medical Supply and manufactured by the manufacturer of the ENDOR 2000. Because the electrical parameters mimic those of the 804S III, it is claimed that the ENDOR 2000 is substantially equivalent to an existing, legally marketed product.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1