Cleared Traditional

K021075 - MECHANICAL DAILY USE WHEELCHAIR

K021075 is an FDA 510(k) clearance for MECHANICAL DAILY USE WHEELCHAIR, manufactured by First World Services, Inc.. The device is a Class 1 Physical Medicine device with product code IOR cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K021075 · First World Services, Inc. · Physical Medicine device
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Jul 2002
Decision
101d
Days
Class 1
Risk

K021075 is an FDA 510(k) clearance for the MECHANICAL DAILY USE WHEELCHAIR. Classified as Wheelchair, Mechanical (product code IOR), Class I - General Controls.

Submitted by First World Services, Inc. (Baltimore, US). The FDA issued a Cleared decision on July 12, 2002 after a review of 101 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.

FDA 510(k) Submission Details - K021075

510(k) Number K021075 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 2002
Decision Date July 12, 2002
Days to Decision 101 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
15d faster than avg
Panel avg: 116d · This submission: 101d
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 466
Devices cleared under the same product code (IOR) and FDA review panel - the closest regulatory comparables to K021075.
TRANSFER COMPANION HR 3000 MANUAL WHEELCHAIR
K022699 · Forever Young Ent. Co., Ltd. · Sep 2002
DELUXE MANUAL WHEELCHAIR HW 4000
K022700 · Forever Young Ent. Co., Ltd. · Sep 2002
MANUAL WHEELCHAIR
K022825 · Major Mobility Products, Inc. · Sep 2002
KARMA 800 SERIES MANUAL WHEELCHAIR
K021866 · Vestil Manufacturing Corp. · Jun 2002
ACCOMMODATOR WHEELCHAIR, MODEL #2000X
K021145 · Marken International, Inc. · May 2002
CAT ACTIVE WHEELCHAIR
K020737 · Movingpeople.Net · Mar 2002
K021075 · MECHANICAL DAILY USE WHEELCHAIR
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