Cleared Traditional

K002876 - JOBSITE ENHANCED MOBILITY CHAIR, MODEL JEM

K002876 is an FDA 510(k) clearance for JOBSITE ENHANCED MOBILITY CHAIR, manufactured by Suiter Medical LLC. The device is a Class 1 Physical Medicine device with product code IOR cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K002876 · Suiter Medical LLC · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2000
Decision
27d
Days
Class 1
Risk

K002876 is an FDA 510(k) clearance for the JOBSITE ENHANCED MOBILITY CHAIR, MODEL JEM. Classified as Wheelchair, Mechanical (product code IOR), Class I - General Controls.

Submitted by Suiter Medical LLC (Mc Cook, US). The FDA issued a Cleared decision on October 11, 2000 after a review of 27 days - a notably fast clearance cycle.

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: 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 - K002876

510(k) Number K002876 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 14, 2000
Decision Date October 11, 2000
Days to Decision 27 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
89d faster than avg
Panel avg: 116d · This submission: 27d
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 452
Devices cleared under the same product code (IOR) and FDA review panel - the closest regulatory comparables to K002876.
EZ-TRAVELER 3000 SERIES MANUAL WHEELCHAIR
K002670 · Jiangsu Intco Medical Equipment & Supply Co., Ltd. · Oct 2000
EZ-TRAVELER 2500 SERIES MANUAL WHEELCHAIR
K002671 · Jiangsu Intco Medical Equipment & Supply Co., Ltd. · Oct 2000
EZ-COMFORT TRANSPORTER 2000 SERIES
K002673 · Jiangsu Intco Medical Equipment & Supply Co., Ltd. · Oct 2000
PLAINSENSE WHEELCHAIR
K001909 · Plainsense Wheelchairs, Inc. · Aug 2000
KARMAN WHEELCHAIR
K002167 · Karman Healthcare, Inc. · Aug 2000
KARMAN WHEELCHAIR
K002202 · Karman Healthcare, Inc. · Aug 2000
K002876 · JOBSITE ENHANCED MOBILITY CHAIR, MODEL JEM
Download PDF FDA Summary Suiter Medical LLC