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510(k) Data Aggregation

    K Number
    K060251
    Device Name
    WH CONVERTIBLE LIGHTWEGHT WHEELCHAIR, MODEL WHL100
    Manufacturer
    WELL HOME HEALTH PRODUCTS CO.
    Date Cleared
    2006-03-08

    (36 days)

    Product Code
    IOR
    Regulation Number
    890.3850
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    K041337
    Why did this record match?
    Device Name :

    WH CONVERTIBLE LIGHTWEGHT WHEELCHAIR, MODEL WHL100

    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 seated position.

    Device Description

    The WH Convertible Lightweight Wheelchair WHL100 is an indoor / outdoor wheelchair that has a base with four-wheeled with a seat. The device can be disassembled for transport and it is foldable easily. The device uses a standard sling type back and seat, the upholstery fabric meets the California Technical Bulletin CAL 117 standard for flame retardant.

    AI/ML Overview

    This K060251 submission describes the WH Convertible Lightweight Wheelchair, Model WHL100.

    Here's an analysis of the provided information regarding acceptance criteria and the supporting study:

    1. Acceptance Criteria and Reported Device Performance

    Acceptance CriteriaReported Device Performance
    Meet applicable performance requirements as specified in ANSI/RESNA WC vol. 1.Device meets ANSI/RESNA WC vol. 1 standards.
    Meet applicable performance requirements as specified in ISO 7176 Wheelchair Standards.Device meets ISO 7176 Wheelchair Standards.
    Weight limit of the predicate device is 100kgs/220lbs. Subject device's weight limit.Subject device (WHL100) has a weight limit of 250lbs, exceeding the predicate device (ML-300).
    Overall appearance differences are not safety aspect.The overall appearance differences between the WHL100 and ML-300 are deemed not to be a safety aspect.
    Seat heights between new device and predicate device have small difference, not leading to any safety hazard.The small difference in seat heights between the WHL100 and ML-300 are stated not to lead to any safety hazard.
    Hanger and rear axle designs are the same as the predicate device.Hanger and rear axle designs are the same.
    Caster sizes are the same as the predicate device.Caster sizes are the same.
    Weight of the new device is heavier, allowing users to feel more stable during transport.The new device is heavier, contributing to a feeling of more stability during transport.
    Upholstery fabric meets California Technical Bulletin CAL 117 standard for flame retardancy.The upholstery fabric meets the California Technical Bulletin CAL 117 standard for flame retardant.

    Study Description:

    The study referenced is a performance testing comparison to established wheelchair standards and a substantial equivalence comparison to a legally marketed predicate device.

    2. Sample Size and Data Provenance

    • Test Set Sample Size: The document does not specify a numerical sample size for the devices tested against the standards or for the comparison. It states "The WH Convertible Lightweight Wheelchair WHL100" which implies at least one unit was tested to meet the standards, and also refers to "the two devices" in the comparison.
    • Data Provenance: The device manufacturer (WELL HOME HEALTH PRODUCTS CO.) is located in Taichung County, Taiwan, ROC. The testing would presumably have been conducted there or by a certified laboratory on behalf of the manufacturer. The data is prospective in the sense that performance testing was conducted for this specific device to demonstrate compliance. The comparison to a predicate device is retrospective in nature, focusing on existing attributes of the predicate.

    3. Number of Experts and Qualifications

    • The document does not specify the number of experts used to establish ground truth or their qualifications. The performance testing against ANSI/RESNA WC vol. 1 and ISO 7176 standards would typically be performed by accredited testing laboratories with engineers and technicians experienced in wheelchair testing. The substantial equivalence comparison is a regulatory assessment.

    4. Adjudication Method

    • The document does not describe an adjudication method in the context of expert review for a test set. This type of submission (510(k)) relies on performance testing against established standards and a direct comparison to a predicate device's characteristics, rather than subjective expert consensus on a test set.

    5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

    • No MRMC study was done. This device is a mechanical wheelchair, not an AI-assisted diagnostic or operative device, so an MRMC study comparing human readers with and without AI assistance is not applicable.

    6. Standalone (Algorithm Only) Performance

    • No standalone algorithm performance was done. This device is a hardware product (mechanical wheelchair), not a software algorithm.

    7. Type of Ground Truth Used

    • Established Industry Standards and Predicate Device Characteristics: The ground truth for performance testing is defined by recognized international and national standards (ANSI/RESNA WC vol. 1 and ISO 7176). For the substantial equivalence comparison, the ground truth is the established characteristics and performance of the legally marketed predicate device (PRO WALKER ML-300 Foldable Wheelchair, K041337).

    8. Sample Size for the Training Set

    • Not applicable. This is a mechanical device, not a machine learning model, so there is no "training set" in the context of AI/ML.

    9. How the Ground Truth for the Training Set was Established

    • Not applicable. As above, there is no training set for this type of device.
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