Cleared Traditional

K000869 - LA PERSONAL SCOOTER

K000869 is an FDA 510(k) clearance for LA PERSONAL SCOOTER, manufactured by Assembled Products Corp.. The device is a Class 2 Physical Medicine device with product code INI cleared through the Traditional 510(k) pathway after a 124-day FDA review.

K000869 · Assembled Products Corp. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2000
Decision
124d
Days
Class 2
Risk

K000869 is an FDA 510(k) clearance for the LA PERSONAL SCOOTER. Classified as Vehicle, Motorized 3-wheeled (product code INI), Class II - Special Controls.

Submitted by Assembled Products Corp. (Rogers, US). The FDA issued a Cleared decision on July 19, 2000 after a review of 124 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 Assembled Products Corp. devices

FDA 510(k) Submission Details - K000869

510(k) Number K000869 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 2000
Decision Date July 19, 2000
Days to Decision 124 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
9d slower than avg
Panel avg: 115d · This submission: 124d
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 217
Devices cleared under the same product code (INI) and FDA review panel - the closest regulatory comparables to K000869.
LASER 3 SPSC300
K003058 · Pride Mobility Products Corp. · Mar 2001
LASER 4SPSC340
K003059 · Pride Mobility Products Corp. · Mar 2001
MODELS LYNX AND PANTHER MOTORIZED SCOOTERS, MODELS LYNX SX-3, LYNX SX-3P, LYNX LX-3, LYNX LX-3, PANTHER LX-4
K010135 · Invacare Corp. · Feb 2001
TMC-EASY-302
K984565 · Tmc Magnetics & Machinery Corp. · Feb 2000
GLORY
K994127 · Pillar Technology, Inc. · Feb 2000
ELECTRIC MOBILITY CAVALIER SCOOTERS
K991281 · Electric Mobility Corp. · Oct 1999