Cleared Traditional

K094047 - 18 STANDARD WHEELCHAIR, MODEL MS005-4, 18 RECLINING WHEELCHAIR , MODEL MS008-1, 14 PEDIATRIC WHEELCHAIR

K094047 is an FDA 510(k) clearance for 18 STANDARD WHEELCHAIR, manufactured by Modern Rehabilitation Solutions Co., Ltd.. The device is a Class 1 Physical Medicine device with product code IOR cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K094047 · Modern Rehabilitation Solutions Co., Ltd. · Physical Medicine device
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Mar 2010
Decision
81d
Days
Class 1
Risk

K094047 is an FDA 510(k) clearance for the 18 STANDARD WHEELCHAIR, MODEL MS005-4, 18 RECLINING WHEELCHAIR , MODEL MS008-.... Classified as Wheelchair, Mechanical (product code IOR), Class I - General Controls.

Submitted by Modern Rehabilitation Solutions Co., Ltd. (Greenwood Village, US). The FDA issued a Cleared decision on March 22, 2010 after a review of 81 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 - K094047

510(k) Number K094047 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 31, 2009
Decision Date March 22, 2010
Days to Decision 81 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 116d · This submission: 81d
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 424
Devices cleared under the same product code (IOR) and FDA review panel - the closest regulatory comparables to K094047.
ORION II (HEAVY DUTY 350 LBS AND 500 LBS)
K101277 · Future Mobility Healthcare, Inc. · Jun 2010
MECHANICAL WHEELCHAIR, MODEL DS 202-S
K100824 · Suzhou KD Medical · May 2010
MULTI FRAME WHEELCHAIR
K100084 · R82 A/S · Apr 2010
HUAYI K-SERIES LIGHTWEIGHT WHEELCHAIR K3/K4
K091482 · Danyang Huayi Medical Supply & Equipment Co, Ltd. · Jul 2009
TREVAIR CHAIR
K091478 · Patmont Motor Werks, Inc. · Jun 2009
MARVEL PEDIATRIC WHEELCHAIR
K083847 · Rogue Wheelchairs, Inc. · Jan 2009
K094047 · 18 STANDARD WHEELCHAIR, MODEL MS005-4, 18 RECLINING WHEELCHAIR , MODEL MS008-1, 14 PEDIATRIC WHEELCHAIR
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