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510(k) Data Aggregation

    K Number
    K972564
    Device Name
    TILT MASTER CG SYSTEM (CENTER OF GRAVITY), TILT-N-SPACE-SEAT
    Manufacturer
    MECHANICAL APPLICATION DESIGNS, INC.
    Date Cleared
    1997-08-25

    (47 days)

    Product Code
    ITI
    Regulation Number
    890.3860
    Why did this record match?
    Applicant Name (Manufacturer) :

    MECHANICAL APPLICATION DESIGNS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    THE TILTMASTER KIT DESIGN IS INTENDED FOR USE ON A POWER AND MANUAL WHEELCHAIR TO PROVIDE PATIENTS WITH POSTERIOR TILT FOR POSITIONING AND SEATING PRESSURE RELIEF.
    Device Description
    THE TILT MASTER CG SYSTEMS (CENTER OF GRAVITY), IS AN AFTERMARKET KIT CONSISTING OF A LINEAR ACTUATOR WITH 900 POUNDS CAPACITY, ALUMINUM AND STEEL BRACKETS, WIRING HARNESS TO SUPPLY VOLTAGE TO THE ACTUATOR, AND A MERCURY SWITCH DRIVER LOCKOUT WHICH RENDERS THE WHEELCHAIR INOPERABLE WHEN TILTED BEYOND 15 DEGREES. THE CG SYSTEM KIT IS DESIGNED TO CONVERT A POWERED OR MANUAL STANDARD WHEELCHAIR TO A POWER RECLINE. THE TILT MASTER CG SYSTEM USES A CENTER OF GRAVITY DESIGN TO MOVE THE PATIENTS CENTER OF GRAVITY FORWARD 6" AS THE SYSTEM TILTS. THIS PROVIDES ADDED SECURITY WHEN IN THE TILTED POSITION. THE TILT MASTER CG SYSTEM ALLOWS THE USER TO HAVE 5 TO 55 DEGREE RANGE OF TILT. THE TILT MASTER CG SYSTEM IS DESIGNED SO IF ANY CATASTROPHIC FAILURE OCCURS WHILE THE SEAT IS IN THE TILT POSITION, THE SAFETY NUT ON THE ACTUATOR WILL ALLOW THE DRIVER TO PUT THE SEAT BACK ON THE DRIVE POSITION AND WILL DISABLE THE TILT MECHANISM. THE DRIVER WILL BE UNABLE TO PUT THE SYSTEM IN THE TILT POSITION ONCE THIS OCCURS.
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    K Number
    K972563
    Device Name
    LIFT MASTER
    Manufacturer
    MECHANICAL APPLICATION DESIGNS, INC.
    Date Cleared
    1997-08-22

    (44 days)

    Product Code
    ITI, 890
    Regulation Number
    890.3860
    Why did this record match?
    Applicant Name (Manufacturer) :

    MECHANICAL APPLICATION DESIGNS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    THE LIFT MASTER ELEVATING POWER SEAT ASSEMBLY DESIGN IS INTENDED FOR USE ON A POWER AND MANUAL WHEELCHAIR. THE LIFT MASTER WILL ELEVATE PATIENTS TO A GREATER HEIGHT THAN THAT OF THE CONVENTIONAL SEAT HEIGHT OF A WHEELCHAIR.
    Device Description
    THE LIFT MASTER CONSISTS OF A BALL DRIVE PEDESTAL ACTUATOR WITH A LOAD CAPACITY OF 500 LBS., ALUMINUM AND STEEL BRACKETS, SAFETY CABLE, AND WIRING HARNESS. THE LIFT MASTER BEGINS WITH A SEAT TO FLOOR HEIGHT OF 17 1/2" AND ELEVATES 8" TO AN UPPER LIMIT OF 25 1/2". OTHER RANGES WILL BE AVAILABLE UPON REQUEST. THE SYSTEM HAS A SPEED REDUCTION CAPABILITY WHILE IN THE LIFTED POSITION. THE LIFT MASTER HAS A WEIGHT LIMIT OF 250 LBS. AND A HEIGHT LIMIT OF 6'. OPERATES ON REAR WHEEL DRIVE AND OFFERS CUSTOM SEATING CAPABILITIES.
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    K Number
    K961744
    Device Name
    TK40 - TILTMASTER
    Manufacturer
    MECHANICAL APPLICATION DESIGNS, INC.
    Date Cleared
    1996-07-25

    (110 days)

    Product Code
    ITI
    Regulation Number
    890.3860
    Why did this record match?
    Applicant Name (Manufacturer) :

    MECHANICAL APPLICATION DESIGNS, INC.

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