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510(k) Data Aggregation

    K Number
    K022697
    Device Name
    TEH LIN JUPITER POWER CHAIR, MODEL TL-320
    Manufacturer
    TEH LIN PROSTHETIC & ORTHOPAEDIC, INC.
    Date Cleared
    2003-01-24

    (164 days)

    Product Code
    ITI
    Regulation Number
    890.3860
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    TEH LIN JUPITER POWER CHAIR, MODEL TL-320

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The device is intended for medical purposes to provide mobility to persons restricted to a sitting position.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a letter from the FDA regarding a 510(k) premarket notification for a powered wheelchair. It does not contain information about acceptance criteria or a study proving the device meets those criteria. My analysis indicates that the letter confirms the device (Teh Lin Jupiter Power Chair, TL-320) is substantially equivalent to legally marketed predicate devices, allowing it to proceed to market. The letter is a regulatory approval, not a technical report detailing performance testing.

    Therefore, I cannot provide the requested information. The document does not contain details about:

    1. A table of acceptance criteria and reported device performance.
    2. Sample sizes or data provenance for a test set.
    3. Number or qualifications of experts for ground truth.
    4. Adjudication method for a test set.
    5. A multi-reader multi-case (MRMC) comparative effectiveness study.
    6. A standalone (algorithm only) performance study.
    7. The type of ground truth used.
    8. Sample size for the training set.
    9. How ground truth for the training set was established.
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