Cleared Traditional

K954044 - SIDEKICK POWER WHEELCHAIR

K954044 is an FDA 510(k) clearance for SIDEKICK POWER WHEELCHAIR, manufactured by 21st Century Scientific, Inc.. The device is a Class 2 Physical Medicine device with product code ITI cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K954044 · 21st Century Scientific, Inc. · Physical Medicine device
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Oct 1995
Decision
45d
Days
Class 2
Risk

K954044 is an FDA 510(k) clearance for the SIDEKICK POWER WHEELCHAIR. Classified as Wheelchair, Powered (product code ITI), Class II - Special Controls.

Submitted by 21st Century Scientific, Inc. (Coeur D' Alene, US). The FDA issued a Cleared decision on October 13, 1995 after a review of 45 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 21st Century Scientific, Inc. devices

FDA 510(k) Submission Details - K954044

510(k) Number K954044 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 1995
Decision Date October 13, 1995
Days to Decision 45 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
70d faster than avg
Panel avg: 115d · This submission: 45d
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 376
Devices cleared under the same product code (ITI) and FDA review panel - the closest regulatory comparables to K954044.
JAZZY
K945936 · Pride Health Care, Inc. · May 1996
ORTHOFAB WHEELCHAIR
K952675 · Orthofab, Inc. · May 1996
POWERCHAIR
K954135 · Wheelcare Scooters, Inc. · Apr 1996
MODEL INT/DL40I MICRO COMPUTER CONTROLLER FOR POWER WHEELCHAIRS
K950724 · Invacare Corp. · Aug 1995
GERONIMO
K935750 · Redman, Inc. · Feb 1995
GERONIMO PR
K935751 · Redman, Inc. · Feb 1995