(168 days)
The "T-2000 Power Tilt System" is an aftermarket Power Tilt in Space Seating System utilizing the wheelchair manufactures base frame and seat frame. The T-2000 Power Tilt Seating System attaches between the base frame and seat frame of the wheelchair, allowing for the tilting action of the system upon activation of the Low-Amp Toggle Switch or any alternative low-amp switch that the client may choose to operate. The T-2000 system has no software based components. The T-2000 system is appropriate for individuals who require chances in position without the help of an attendant. Power tilt systems are utilized by individuals with a variety of physical disabilities. Some of the indications for use include:
- The reduction of sitting pressure, may prevent Decubitus Ulcers
- Gravity assisted positioning .
- . Increased sitting stability
- Assistance in feeding, Improved Swallowing .
- Increased Respiratory Function .
- . Decrease Muscle Tone
- Comfort Adjustments
THE ACCELERATED REHAB DESIGNS "T-2000 POWER TILT SEATING SYSTEM" IS A CENTER OF GRAVITY DESIGN. AFTERMARKET POWER TILT IN SPACE SYSTEM THAT UTILIZES THE WHEELCHAIR MANUFACTURES EXISTING TUBULAR SEAT FRAME, ARMRESTS, FRONT RIGGING, BACK ASSEMBLY AND OPTTONAL ACCESSORIES. THE SYSTEM CONSISTS OF STEEL AND ALUMINUM BRACKETS AND MOUNTING HARDWARE. THE T-2000 SYSTEM UTILIZES A LINEAR ACTUATOR MANUFACTURED BY LINAK CORPORATION, AND HAS A LOAD CAPACITY OF 750 POUNDS. THE LINAK ACTUATOR HAS AN INTERNAL SAFETY NUT ATTACHED TO THE BALL SPINDLE IN THE CASE OF ACTUATOR FATURE. THIS SAFETY NUT WILL NOT ALLOW THE SEATING SYSTEM TO TILT BACKWARD ANY FARTHER THAN THE FULL STROKE OF THE ACTUATOR. THIS ELIMINATES THE POSSIBILITY OF THE CLIENT TIPPING OVER BACKWARD DUE TO ACTUATOR FAILURE. THE WHEELCHAIR SEAT FRAME IS ATTACHED TO THE WHEELCHAIR BASE FRAME VIA THE T-2000 SYSTEM MOUNTING HARDWARE BRACKETS AND HARDWARE. THE T-2000 SYSTEM IS ACTIVATED BY A DUAL DIRECTION "LOW-AMP" TOGGLE SWITCH. INCLUDED IN THE WIRING HARNESS IS A LOW-AMP SWITCH INTERFACE BOX THAT WILL ACCEPT MOST INDUSTRY WIDE LOW-AMP SINGLE AND DUAL SWITCHES UTILIZING AN 1/8™ INCH MALE PHONO JACK LEAD. AS THE TOGGLE SWITCH IS ACTIVATED. THE SEATING SYSTEM WILL BEGIN TO TILT. AS THE SYSTEM IS TILTING. THE SEATING SYSTEM IS ALSO MOVING FORWARD MAINTAINING THE CENTER OF GRAVITY OF THE CLIENT ON THE WHEELCHAIRS BASE FRAME. THIS ALLOWS FOR USE OF SHORTER BASE FRAMES FOR A WIDER RANGE OF INDIVIDUALS. THE HEAVIER, TALLER CLIENT CAN HAVE THE SAME ACCESS AND PERFORMANCE AS THE SMALLER, LIGHTER CLIENT. THE T-2000 HAS A STANDARD TILT RANGE OF ZERO TO 50 DEGREES. CUSTOM ANGLES ARE AVAILABLE. THERE IS A MINI-MICRO SWITCH ATTACHED TO THE SYSTEMS MOUNTING HARDWARE THAT RESTRICTS THE CLIENT FROM DRIVING BEYOND 20 DEGREES OF TILT.
This document is a 510(k) summary for the "T-2000 Power Tilt Seating System." It outlines the device description, intended use, and substantial equivalence to predicate devices. However, it does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.
Therefore, I cannot provide the requested information. The document focuses on regulatory submission for market clearance based on substantial equivalence, not on the performance testing against specific acceptance criteria.
§ 890.3860 Powered wheelchair.
(a)
Identification. A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class II (performance standards).