Cleared Traditional

K873500 - MINI CROSSER BATTERY POWERED WHEELCHAIR

K873500 is an FDA 510(k) clearance for MINI CROSSER BATTERY POWERED WHEELCHAIR, manufactured by Heisteel DK Aps. The device is a Class 2 Physical Medicine device with 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

FDA 510(k) Submission Details - K873500

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.

INI Device Classification - Class 2, Special Controls

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.

Regulatory Peers - INI Vehicle, Motorized 3-wheeled

All 247
Devices cleared under the same product code (INI) and FDA review panel - the closest regulatory comparables to K873500.
FORTRESS 2000FS 3-WHEEL SCOOTER
K895693 · Fortress Scientific , Ltd. · Oct 1989
FORTRESS MODEL 2200FS FRONT WHEEL DRIVE SCOOTER
K895694 · Fortress Scientific , Ltd. · Oct 1989
CARRETTE 3 WHEELED MOTORIZED CART
K891609 · Everest & Jennings, Inc. · Apr 1989
MOBIE SCOOTER
K851256 · Everest & Jennings, Inc. · Jun 1985
MOBIE
K832727 · Everest & Jennings, Inc. · Sep 1983