E-2000 POWER ELEVATING SEAT SYSTEM - Ard-EP320
by Accelerated Rehab Designs, Inc.
510(k) K992828
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK992828 | Date3 Feb 2000 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- ITI
- Models / Variants
- Ard-EP320
- Device Class
- Class II
- Regulation
- 21 CFR Part 890.3860
- Advisory Committee
- Physical Medicine
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The E-2000 Power Elevating Seat System is a powered wheelchair accessory designed to elevate the seat to floor height. It is classified as a Powered Wheelchair under FDA product code ITI, featuring a motion system with a ball drive tower actuator. The system is engineered to enhance user accessibility by raising individuals seated in manual or power wheelchairs above standard seat height, improving interaction with surfaces or objects at floor level.
The system is supplied as a reusable, non-sterile medical device intended for clinical and home use. It includes mounting hardware and brackets, with a load capacity of 500 pounds. The E-2000 received FDA 510(k) clearance under the Traditional pathway, classified as Class II with Special Controls. It is regulated under FDA regulation number 890.3860 and is intended for use in physical medicine settings.
Other devices from Accelerated Rehab Designs, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the E-2000 Power Elevating Seat System used for?
The E-2000 Power Elevating Seat System is designed to elevate the seat of manual or power wheelchairs to floor height. This feature enhances accessibility by allowing users to interact more easily with surfaces or objects at floor level, such as counters, tables, or low surfaces, improving independence and functionality in both clinical and home settings.
Is the E-2000 Power Elevating Seat System reusable or single-use?
The E-2000 Power Elevating Seat System is a reusable medical device. It is not intended for single-use and is engineered to withstand repeated use in both clinical and home environments, provided it is maintained according to manufacturer guidelines.
What is the load capacity of the E-2000 Power Elevating Seat System?
The system is rated for a maximum load capacity of 500 pounds. This ensures safe and reliable operation for a wide range of users, including those with higher body weights, while maintaining stability and performance during elevation.
How is the E-2000 Power Elevating Seat System supplied, and what does it include?
The E-2000 Power Elevating Seat System is supplied as a complete unit, including the motion system with a ball drive tower actuator, mounting hardware, and brackets. It is intended for direct installation on compatible wheelchairs, requiring no additional accessories beyond what is provided.
What regulatory pathway was followed for the E-2000 Power Elevating Seat System?
The E-2000 Power Elevating Seat System received FDA 510(k) clearance under the Traditional pathway. It is classified as a Class II medical device with Special Controls and is regulated under FDA regulation number 890.3860, specifically for powered wheelchairs under product code ITI.