Cleared Traditional

CALIFORNIA COMFORT FOUR WHEEL (K895384) - FDA 510(k) Clearance

Class II Physical Medicine device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K895384 · Jubilee Scooters, Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1989
Decision
19d
Days
Class 2
Risk

K895384 is an FDA 510(k) clearance for the CALIFORNIA COMFORT FOUR WHEEL. Classified as Wheelchair, Special Grade (product code IQC), Class II - Special Controls.

Submitted by Jubilee Scooters, Inc. (Foster City, US). The FDA issued a Cleared decision on September 18, 1989 after a review of 19 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3880 - 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 Jubilee Scooters, Inc. devices

Submission Details

510(k) Number K895384 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 1989
Decision Date September 18, 1989
Days to Decision 19 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
96d faster than avg
Panel avg: 115d · This submission: 19d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IQC Wheelchair, Special Grade
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.3880
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.