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510(k) Data Aggregation

    K Number
    K140023
    Device Name
    ELEVATION
    Manufacturer
    PDG PRODUCT DESIGN GROUP, INC.
    Date Cleared
    2014-10-16

    (283 days)

    Product Code
    IOR
    Regulation Number
    890.3850
    Why did this record match?
    Applicant Name (Manufacturer) :

    PDG PRODUCT DESIGN GROUP, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Elevation Manual Wheelchair is intended to provide mobility to persons limited to a seated position.
    Device Description
    The PDG Product Design Group, Inc. Elevation Manual Wheelchair (Elevation) is a manually operated, user propelled, manual, mechanical wheelchair. Its intended function and use is to provide mobility to persons ages 12 and up (adolescents and adults) limited to a seated position. It is an ultra-light, rigid (non-folding frame) type wheelchair. The device consists primarily of a lower frame assembly, a seat sling, a back rest and back upholstery, large rear wheels with hand rims for self-propelling the chair and front swivel type pivoting casters for turning. The Elevation also has seat height and back rest recline angle adjustment capability that allow the user to self-adjust either the seat to floor height or the back rest recline angle while seated in the wheelchair. The Elevation is capable of up to 5 inches of rear to front seat height difference.
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    K Number
    K063736
    Device Name
    FUZE MECHANICAL WHEELCHAIR, MODELS T20 AND T50
    Manufacturer
    PDG PRODUCT DESIGN GROUP, INC.
    Date Cleared
    2007-01-17

    (30 days)

    Product Code
    IOR
    Regulation Number
    890.3850
    Why did this record match?
    Applicant Name (Manufacturer) :

    PDG PRODUCT DESIGN GROUP, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To provide mobility to persons limited to a seated position.
    Device Description
    The PDG Models Fuze T20 and T50 wheelchairs are manually operated, self propelled mechanical wheelchairs. Their intended function and use is to provide mobility to persons that may be limited to a seated position. They may also be used as attendant propelled transport devices in a health care environment such as a hospital, nursing home or extended care facility. Both wheelchairs include a tilt mechanism which allows the upper frame of the wheelchair to be tilted. This feature is used to provide pressure relief as well as comfort to those users who may be confined to the wheelchair for extended periods of time. The tilt mechanism can also serve as an attendant aid in those situations where a patient needs to be tilted for attendant access.
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    K Number
    K061475
    Device Name
    ASTROTILT MANUAL WHEELCHAIR
    Manufacturer
    PDG PRODUCT DESIGN GROUP, INC.
    Date Cleared
    2006-06-14

    (15 days)

    Product Code
    IOR
    Regulation Number
    890.3850
    Why did this record match?
    Applicant Name (Manufacturer) :

    PDG PRODUCT DESIGN GROUP, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To provide mobility to individuals limited to a sitting position.
    Device Description
    Not Found
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    K Number
    K990557
    Device Name
    THE STELLAR TILT, MANUALLY OPERATED WHEELCHAIR
    Manufacturer
    PDG PRODUCT DESIGN GROUP, INC.
    Date Cleared
    1999-03-22

    (28 days)

    Product Code
    IOR
    Regulation Number
    890.3850
    Why did this record match?
    Applicant Name (Manufacturer) :

    PDG PRODUCT DESIGN GROUP, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the device is in providing mobility to persons restricted to a sitting position.
    Device Description
    The Stellar Tilt, Manually Operated Wheelchair
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    K Number
    K971389
    Device Name
    ECLIPSE 400 MANUALLY OPERATED WHEELCAIR
    Manufacturer
    PDG PRODUCT DESIGN GROUP, INC.
    Date Cleared
    1997-05-09

    (25 days)

    Product Code
    IOR
    Regulation Number
    890.3850
    Why did this record match?
    Applicant Name (Manufacturer) :

    PDG PRODUCT DESIGN GROUP, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K970311
    Device Name
    BENTLEY MANUALLY OPERATED WHEELCHAIR
    Manufacturer
    PDG PRODUCT DESIGN GROUP, INC.
    Date Cleared
    1997-02-14

    (18 days)

    Product Code
    IOR
    Regulation Number
    890.3850
    Why did this record match?
    Applicant Name (Manufacturer) :

    PDG PRODUCT DESIGN GROUP, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K961743
    Device Name
    ECLIPSE 600 MANUALLY OPERATED WHEELCHAIR
    Manufacturer
    PDG PRODUCT DESIGN GROUP, INC.
    Date Cleared
    1996-05-29

    (26 days)

    Product Code
    IOR
    Regulation Number
    890.3850
    Why did this record match?
    Applicant Name (Manufacturer) :

    PDG PRODUCT DESIGN GROUP, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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