Cleared Traditional

K012281 - TRS-2000 POWER TILT/POWER RECLINE SYSTEM

K012281 is an FDA 510(k) clearance for TRS-2000 POWER TILT/POWER RECLINE SYSTEM, manufactured by Accelerated Rehab Designs, Inc.. The device is a Class 2 Physical Medicine device with product code ITI cleared through the Traditional 510(k) pathway after a 12-day FDA review.

K012281 · Accelerated Rehab Designs, Inc. · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2001
Decision
12d
Days
Class 2
Risk

K012281 is an FDA 510(k) clearance for the TRS-2000 POWER TILT/POWER RECLINE SYSTEM. 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 August 1, 2001 after a review of 12 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K012281

510(k) Number K012281 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 2001
Decision Date August 01, 2001
Days to Decision 12 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
104d faster than avg
Panel avg: 116d · This submission: 12d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ITI Device Classification - Class 2, Special Controls

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 593
Devices cleared under the same product code (ITI) and FDA review panel - the closest regulatory comparables to K012281.
HP-5, BATTERY OPERATED, REAR WHEEL DRIVE, POWER WHEELCHAIR
K011744 · Transworld Mobility Distribution, LLC · Aug 2001
MP3U, POWER WHEELCHAIR
K011513 · Merits Health Products., Inc. · Aug 2001
MP-3C POWER BASE CHAIR, MODEL MP3C
K011687 · Merits Health Products., Inc. · Aug 2001
SUPREMA POWERED WHEELCHAIR
K010600 · Luigi Chinetti · Jul 2001
QUANTUM BLAST
K011993 · Pride Mobility Products Corp. · Jul 2001
PRAIRIE CRUISER
K002580 · Raye'S, Inc. · Jul 2001
K012281 · TRS-2000 POWER TILT/POWER RECLINE SYSTEM
Download PDF FDA Summary Accelerated Rehab Des…