Cleared Traditional

K050280 - RUNABOUT WHEELCHAIR

K050280 is an FDA 510(k) clearance for RUNABOUT WHEELCHAIR, manufactured by Access Point Medical, LLC. The device is a Class 1 Physical Medicine device with product code IOR cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K050280 · Access Point Medical, LLC · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2005
Decision
63d
Days
Class 1
Risk

K050280 is an FDA 510(k) clearance for the RUNABOUT WHEELCHAIR. Classified as Wheelchair, Mechanical (product code IOR), Class I - General Controls.

Submitted by Access Point Medical, LLC (Potomac, US). The FDA issued a Cleared decision on April 11, 2005 after a review of 63 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 - K050280

510(k) Number K050280 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 07, 2005
Decision Date April 11, 2005
Days to Decision 63 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
53d faster than avg
Panel avg: 116d · This submission: 63d
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 361
Devices cleared under the same product code (IOR) and FDA review panel - the closest regulatory comparables to K050280.
R. POON MEDICAL PRODUCTS WHEELCHAIRS
K050691 · R. Poon Medical Products Co., Ltd. · Apr 2005
LERADO, AVANTICARE TRANSPORT WHEELCHAIR, MT-3000
K050707 · Lerado Oversea Ltd. Twn Branch (Bvi) · Apr 2005
AXS-1 LITE WHEELCHAIR
K050279 · Access Point Medical, LLC · Apr 2005
TRANSPORT SERIES TRANSPORT CHAIR
K050281 · Access Point Medical, LLC · Apr 2005
CIE FOLDAWAY WHEELCHAIR
K050345 · Carlsbad International Export, Inc. · Mar 2005
LERADO, COSCO
K050290 · Lerado Oversea Ltd. Twn Branch (Bvi) · Feb 2005