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510(k) Data Aggregation

    K Number
    K990813
    Device Name
    REHCOR
    Manufacturer
    ELECTROMED CORP.
    Date Cleared
    1999-04-12

    (32 days)

    Product Code
    ISD, MEA
    Regulation Number
    890.5360
    Why did this record match?
    Applicant Name (Manufacturer) :

    ELECTROMED CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Useful for physiotherapy in redevelopment of muscles or for restoration of motion to joints or for use as an adjunct treatment for obesity. The bicycle would be Class I exempt when sold without measuring capability but is available with ECG and/or blood pressure measuring options thus making it Class II, not exempt. The unit's workload can be controlled by an RS-232 input for connection to ECG stress test systems (supplied by other manufacturers)
    Device Description
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