Cleared Traditional

E-2000 POWER ELEVATING SEAT SYSTEM, MODELS ARD-ESTORM, ARD-EP320, ARD-ELANCER (K992828) - FDA 510(k) Clearance

Class II Physical Medicine device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K992828 · Accelerated Rehab Designs, Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2000
Decision
164d
Days
Class 2
Risk

K992828 is an FDA 510(k) clearance for the E-2000 POWER ELEVATING SEAT SYSTEM, MODELS ARD-ESTORM, ARD-EP320, ARD-ELANCER. Classified as Wheelchair, Powered (product code ITI), Class II - Special Controls.

Submitted by Accelerated Rehab Designs, Inc. (Pinehurst, US). The FDA issued a Cleared decision on February 3, 2000 after a review of 164 days - an extended review cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3860 - the FDA physical medicine device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Accelerated Rehab Designs, Inc. devices

Submission Details

510(k) Number K992828 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 1999
Decision Date February 03, 2000
Days to Decision 164 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
49d slower than avg
Panel avg: 115d · This submission: 164d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ITI Wheelchair, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.3860
Definition 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. Fda Interprets “mobility To Persons Restricted To A Sitting Position” To Mean The Device Type Is Intended To Provide Mobility To Individuals Who Have Mobility Impairments And Require An Assistive Device For Mobility. Note: This Type Of Device Is Not Intended To Climb Stairs (see Product Code: Imk).
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Physical Medicine devices follow this clearance model.

Regulatory Peers - ITI Wheelchair, Powered

All 577
Devices cleared under the same product code (ITI) and FDA review panel - the closest regulatory comparables to K992828.
Power Wheelchair (N5515A, N5516, N5517A, N5519)
K260056 · Zhejiang Innuovo Rehabilitation Devices Co.,Ltd · Jun 2026
Electric Wheelchair (DF506)
K260373 · Jiangsu Yveelt Medical Equipment Co., Ltd. · Jun 2026
Electric Wheelchair (Y207BL)
K253241 · Jiangsu Intco Medical Products Co., Ltd. · May 2026
Power Wheelchair (N5919 series)
K253806 · Zhejiang Innuovo Rehabilitation Devices Co.,Ltd · Apr 2026
Power Wheelchair (OS-R-M01S)
K253952 · Beijing OrionStar Technology Co., Ltd. · Apr 2026
Electric Wheelchair (AL-208S-063)
K253340 · Zhongshan A&J Medical Equipment Co., Ltd. · Apr 2026