Cleared Abbreviated

K080506 - MARTIN CHAIR, MODEL C4S1

K080506 is an FDA 510(k) clearance for MARTIN CHAIR, manufactured by Martin Manufacturing Co., LLC. The device is a Class 1 Physical Medicine device with product code IOR cleared through the Abbreviated 510(k) pathway after a 105-day FDA review.

K080506 · Martin Manufacturing Co., LLC · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2008
Decision
105d
Days
Class 1
Risk

K080506 is an FDA 510(k) clearance for the MARTIN CHAIR, MODEL C4S1. Classified as Wheelchair, Mechanical (product code IOR), Class I - General Controls.

Submitted by Martin Manufacturing Co., LLC (Raleigh, US). The FDA issued a Cleared decision on June 9, 2008 after a review of 105 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

FDA 510(k) Submission Details - K080506

510(k) Number K080506 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 2008
Decision Date June 09, 2008
Days to Decision 105 days
Submission Type Abbreviated
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
11d faster than avg
Panel avg: 116d · This submission: 105d
Pathway characteristics
Standards-based clearance path.

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 441
Devices cleared under the same product code (IOR) and FDA review panel - the closest regulatory comparables to K080506.
DIGNITY 100
K082246 · Dignity Medical Devices, Inc. · Sep 2008
HAIDA MODEL HD11 MANUAL WHEELCHAIR
K082274 · Jiangyin East China Medical Technology Co., Ltd. · Aug 2008
MILLENIUM II
K081665 · Next Mobility, LLC · Jun 2008
MANUAL RIGID MOBILITY WHEELCHAIR
K080270 · Freedom Designs, Inc. · Apr 2008
RTM AND OVAL
K080880 · Next Mobility, LLC · Apr 2008
DANYANG HUAYI K2 AND K7 WHEELCHAIRS
K080207 · Danyang Huayi Medical Supply & Equipment Co, Ltd. · Mar 2008
K080506 · MARTIN CHAIR, MODEL C4S1
Download PDF FDA Summary Martin Manufacturing …