Cleared Traditional

K063196 - LANDLEX, MODEL S403X

K063196 is an FDA 510(k) clearance for LANDLEX, manufactured by Besteam Technology, Inc.. The device is a Class 2 Physical Medicine device with product code INI cleared through the Traditional 510(k) pathway after a 95-day FDA review.

K063196 · Besteam Technology, Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2007
Decision
95d
Days
Class 2
Risk

K063196 is an FDA 510(k) clearance for the LANDLEX, MODEL S403X. Classified as Vehicle, Motorized 3-wheeled (product code INI), Class II - Special Controls.

Submitted by Besteam Technology, Inc. (Banqiao, TW). The FDA issued a Cleared decision on January 23, 2007 after a review of 95 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 Besteam Technology, Inc. devices

FDA 510(k) Submission Details - K063196

510(k) Number K063196 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 20, 2006
Decision Date January 23, 2007
Days to Decision 95 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
20d faster than avg
Panel avg: 115d · This submission: 95d
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 172
Devices cleared under the same product code (INI) and FDA review panel - the closest regulatory comparables to K063196.
VICTORY, 4 WHEEL SCOOTER / MODEL, # SC1740
K071949 · Pride Mobility Products Corp. · Aug 2007
HEARTWAY LIGHTWEIGHT POWER MOBILITY SCOOTER, S33
K071007 · Heartway Medical Products Co., Ltd. · Apr 2007
HEARTWAY POWER TILT SEATING SYSTEM POWER CHAIR, P17RT
K070493 · Heartway Medical Products Co., Ltd. · Mar 2007
GO GO ELITE TRAVELLER PLUS 4 WHEEL SCOOTER, MODEL SC54
K063389 · Pride Mobility Products Corp. · Nov 2006
WU'S 3-WHEELED NEO SCOOTER, MODEL WT-T3E
K062790 · Wu'S Tech Co., Ltd. · Oct 2006
GO GO MINI, MODEL SC30
K062160 · Pride Mobility Products Corp. · Sep 2006