Cleared Traditional

K942075 - VECTOR POWER WHEELCHAIR

K942075 is an FDA 510(k) clearance for VECTOR POWER WHEELCHAIR, manufactured by Vector Mobility, Inc.. The device is a Class 2 Physical Medicine device with product code ITI cleared through the Traditional 510(k) pathway after a 47-day FDA review.

K942075 · Vector Mobility, Inc. · Physical Medicine device
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Jun 1994
Decision
47d
Days
Class 2
Risk

K942075 is an FDA 510(k) clearance for the VECTOR POWER WHEELCHAIR. Classified as Wheelchair, Powered (product code ITI), Class II - Special Controls.

Submitted by Vector Mobility, Inc. (Fresno, US). The FDA issued a Cleared decision on June 15, 1994 after a review of 47 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3860 - 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.

View all Vector Mobility, Inc. devices

FDA 510(k) Submission Details - K942075

510(k) Number K942075 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received April 29, 1994
Decision Date June 15, 1994
Days to Decision 47 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
68d faster than avg
Panel avg: 115d · This submission: 47d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ITI Device Classification - Class 2, Special Controls

Product Code ITI Wheelchair, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.3860
Definition A Powered Wheelchair Is A Battery-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 Require An Assistive Device For Mobility. Note: This Type Of Device Is Not Intended To Climb Stairs (see Product Code: Imk).
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Physical Medicine devices follow this clearance model.

Regulatory Peers - ITI Wheelchair, Powered

All 404
Devices cleared under the same product code (ITI) and FDA review panel - the closest regulatory comparables to K942075.
ROAD SAVAGE
K940920 · Redman, Inc. · Feb 1995
ROAD WARRIOR
K935749 · Redman, Inc. · Jan 1995
POWER RECLINER
K944423 · Sunrise Medical, Inc. · Nov 1994
MODEL MCC - MKIV MICRO COMPUTER CONTROLS
K940972 · Invacare Corp. · Jun 1994
KID POWER
K925865 · Everest & Jennings, Inc. · Mar 1994
FORTRESS C-500 MICROPROCESSOR CONTROLLER
K930088 · Fortress Scientific , Ltd. · Mar 1994