Cleared Traditional

K873895 - HOT WHEELS

K873895 is an FDA 510(k) clearance for HOT WHEELS, manufactured by Everest & Jennings, Inc.. The device is a Class 2 Physical Medicine device with product code ITI cleared through the Traditional 510(k) pathway after a 61-day FDA review.

K873895 · Everest & Jennings, Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1987
Decision
61d
Days
Class 2
Risk

K873895 is an FDA 510(k) clearance for the HOT WHEELS. Classified as Wheelchair, Powered (product code ITI), Class II - Special Controls.

Submitted by Everest & Jennings, Inc. (Camarillo, US). The FDA issued a Cleared decision on November 24, 1987 after a review of 61 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.

FDA 510(k) Submission Details - K873895

510(k) Number K873895 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 1987
Decision Date November 24, 1987
Days to Decision 61 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
55d faster than avg
Panel avg: 116d · This submission: 61d
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 598
Devices cleared under the same product code (ITI) and FDA review panel - the closest regulatory comparables to K873895.
WHEEL-CHAIR W/MOTOR DRIVE
K880707 · Paul Weiser Co. · Mar 1988
TARGA (WHEELCHAIR)
K880423 · A-Bec Mobility, Inc. · Feb 1988
NOVA TRANSFER SYSTEM, MODEL XXX
K874448 · Nova Technology Corp. · Dec 1987
GALAXY POWERED WHEELCHAIR
K870532 · Global Research, Inc. · Apr 1987
PERMOBIL MAXIOR
K870224 · Permobil of America · Feb 1987
PERMOBIL EXTERIOR
K870225 · Permobil of America · Feb 1987
K873895 · HOT WHEELS
Download PDF Everest & Jennings, I…