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The "E-2000 Power Tilt Seating System" is an elevating system utilizing the wheelchair manufactures existing tubular seating system with armrests, front rigging, back assembly, and optional accessories.

The Elevating Seat System attaches to the wheelchair base frame and seat frame. By activation of the supplied switch, the system will elevate up to eight (8) inches from its lowest position.

The E-2000 Power Elevating Seat System allows the customer the availability to reach items that in the past, were unreachable to them due to their physical limitations. In the home, the overhead kitchen cabinets are now accessible. In the workplace, the availability of reaching the upper drawers of file cabinets without help from others. Having the ability to interact with fellow students on their level, within the school setting. Some of the customers that may benefit from the use of the E-2000 System are customers with a diagnosis of , but not limited to:

• Muscular Dystrophy (MD) .
• . Multiple Sclerosis (MS)
• Spinal Cord Injury (SCI) .
• Amyotrophic Lateral Sclerosis (ALS) ◆

Accelerated Rehab designs makes no claims as to the therapeutic effectiveness of the product(s) listed. Accelerated Rehab Designs recommends that an accredited rehabilitation therapist and supplier evaluate all customers of its products.

The above indications for use are identical to those of Mechanical Application Designs, Inc Liftmaster System in which we are claiming substantial equivalence.

THE ACCELERATED REHAB DESIGNS, INC "E-2000 POWER ELEVATING SEAT SYSTEM" CONSISTS OF A MOTION SYSTEM, BALL DRIVE TOWER ACTUATOR WITH A LOAD CAPACITY OF 500 POUNDS. THE SYSTEM BRACKETS AND MOUNTING HARDWARE MATERIALS ARE DESIGNED AND MANUFACTURED FROM ALUMINUM AND STEEL. THE E-2000 SYSTEM HAS A BEGINNING SEAT TO FLOOR HEIGHT OF 18 % INCHES, AND WILL ELEVATE 8 INCHES TO AN UPPER LIMIT OF 26 % INCHES. CUSTOM SEAT TO FLOOR HEIGHTS WILL BE AVAILABLE UPON REQUEST WITH A MAXIMUM ELEVATION OF 28 1/2" INCHES.

THE E-2000 ELEVATING SEAT SYSTEM HAS A WEIGHT LIMIT OF 250 POUNDS, OR THE WHEELCHAIR MANUFACTURES BASE FRAME WEIGHT LIMIT. WHICH EVER IS LOWER. ACCELERATED REHAB DESIGNS WILL NOT EXCEED THE WHEELCHAIR MANUFACTURES BASE FRAME LIMIT.

THE E-2000 SYSTEM IS DESIGNED TO BE DRIVEN IN THE LOWERED POSITION. THERE ARE CERTAIN CIRCUMSTANCES THAT MAY ARRISE THAT A CUSTOMER NEEDS TO DRIVE IN THE ELEVATED POSITION. THIS MAY BE AT WORK, HOME, OR IN THE SCHOOL SETTING. THE WHEELCHAIRS ELECTRONICS ARE TO BE PROGRAMMED TO A VERY SLOW DRIVING SPEED WHILE IN THE ELEVATED POSITION. IF IT IS FELT BY THE REHAB PROFESSIONAL THAT A CUSTOMER SHOULD NOT DRIVE WHILE ELEVATED, A MAGNETIC SWITCH DRIVE LOCKOUT IS INSTALLED. ONCE THE CUSTOMER BEGINS TO ELEVATE, THE WHEELCHAIRS DRIVE CONTROLS ARE DISABLED. ONCE BACK IN THE LOWER POSITION, THE CHAIR MAY BE DRIVEN AGAIN.

BY DESIGN, THE E-2000 SYSTEM WILL ALLOW CUSTOM SEATING SYSTEMS TO BE MOUNTED. THE SYSTEM IS ACTIVATED BY THE USE OF A LOW-AMP DUAL DIRECTION TOGGLE SWITCH.

This document [K992828](https://510k.innolitics.com/search/K992828) describes a 510(k) premarket notification for a medical device: the "E-2000 Power Elevating Seat System". This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving safety and effectiveness through clinical trials with defined acceptance criteria and studies.

Therefore, the provided text does not contain the information requested regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, or MRMC studies.

Here's why and what kind of information is present instead:

• 510(k)s vs. PMAs/Clinical Studies: A 510(k) submission primarily compares a new device to a "predicate" device already on the market, arguing that they are "substantially equivalent" in terms of intended use, technological characteristics, and safety/effectiveness. It generally does not require new clinical studies with predetermined acceptance criteria to prove efficacy and safety in the same way a Premarket Approval (PMA) application would for a novel device.
• Focus of this document: The document focuses on:
  • Device Description: What the E-2000 Power Elevating Seat System is, its components, load capacity, elevation range, and design features.
  • Intended Use: How the device is meant to be used (on power and manual wheelchairs to elevate users).
  • Technological Characteristics Comparison: How it compares to the predicate device (Mechanical Application Designs, Inc: Liftmaster K972563) regarding mounting, installation, and versatility.
  • Indications for Use: Specific scenarios and patient populations that might benefit (e.g., Muscular Dystrophy, Multiple Sclerosis).
  • Substantial Equivalence Claim: The central argument that the E-2000 is substantially equivalent to the Liftmaster system.

Therefore, I cannot populate the requested table or provide answers to the specific questions because the document is a 510(k) summary, which does not typically include the detailed study design and results as requested.

The crucial piece of information missing for your request is a dedicated clinical study report with performance metrics, statistical analyses, and predetermined acceptance criteria.

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