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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
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    K851097
    Why did this record match?
    Device Name :

    REHCOR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    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

    Not Found

    AI/ML Overview

    The provided text does not contain information about acceptance criteria or a study proving that a device meets such criteria. The document is a 510(k) premarket notification for an exercise bicycle (REHCOR™) and discusses its classification, indications for use, and substantial equivalence to a predicate device, but it does not detail any performance studies with specific acceptance criteria.

    Therefore, I cannot fulfill your request for the tables and information regarding acceptance criteria and a study from the provided text.

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