Cleared Traditional

K873500 - MINI CROSSER BATTERY POWERED WHEELCHAIR

K873500 is the FDA 510(k) clearance for MINI CROSSER BATTERY POWERED WHEELCHAIR by Heisteel DK Aps. It is a Class 2 Physical Medicine device (product code INI) cleared through the Traditional 510(k) pathway after a 141-day FDA review.

K873500 · Heisteel DK Aps · Physical Medicine device
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Jan 1988
Decision
141d
Days
Class 2
Risk

K873500 is an FDA 510(k) clearance for the MINI CROSSER BATTERY POWERED WHEELCHAIR. Classified as Vehicle, Motorized 3-wheeled (product code INI), Class II - Special Controls.

Submitted by Heisteel DK Aps (Marietta, US). The FDA issued a Cleared decision on January 19, 1988 after a review of 141 days - within the typical 510(k) review window.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3800 - 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.

View all Heisteel DK Aps devices

Submission Details

510(k) Number K873500 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 1987
Decision Date January 19, 1988
Days to Decision 141 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
26d slower than avg
Panel avg: 115d · This submission: 141d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code INI Vehicle, Motorized 3-wheeled
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.3800
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.