Cleared Traditional

K102061 - TREVAIR CHAIR ADULT

K102061 is an FDA 510(k) clearance for TREVAIR CHAIR ADULT, manufactured by Patmont Motor Werks, Inc.. The device is a Class 1 Physical Medicine device with product code IOR cleared through the Traditional 510(k) pathway after a 144-day FDA review.

K102061 · Patmont Motor Werks, Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2010
Decision
144d
Days
Class 1
Risk

K102061 is an FDA 510(k) clearance for the TREVAIR CHAIR ADULT. Classified as Wheelchair, Mechanical (product code IOR), Class I - General Controls.

Submitted by Patmont Motor Werks, Inc. (Minden, US). The FDA issued a Cleared decision on December 13, 2010 after a review of 144 days - within the typical 510(k) review window.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3850 - 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 Patmont Motor Werks, Inc. devices

FDA 510(k) Submission Details - K102061

510(k) Number K102061 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 22, 2010
Decision Date December 13, 2010
Days to Decision 144 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
29d slower than avg
Panel avg: 115d · This submission: 144d
Pathway characteristics
Predicate-based equivalence.

IOR Device Classification - Class 1, General Controls

Product Code IOR Wheelchair, Mechanical
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.3850
Definition A Mechanical Wheelchair Is A Manually 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/or Require An Assistive Device For Mobility.
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - IOR Wheelchair, Mechanical

All 125
Devices cleared under the same product code (IOR) and FDA review panel - the closest regulatory comparables to K102061.
DISCOVERY TMAX MANUAL WHEELCHAIR
K113164 · Otto Bock Healthcare LP · Mar 2013
KIDS ROCK 3 CHAIR
K111739 · Pride Mobility Products Corp. · Aug 2011
CENTRO FAMILY OF MANUAL WHEELCHAIRS
K111045 · Otto Bock Healthcare LP · Jul 2011
BRAVORACER PEDIATRIC MANUAL WHEELCHAIR
K082314 · Otto Bock Healthcare LP · Oct 2008
START JUNIOR
K073512 · Otto Bock Healthcare LP · Jan 2008
QUICKIE QX MANUAL FOLDING WHEELCHAIR
K072153 · Sunrise Medical, Inc. · Sep 2007