Cleared Traditional

K103771 - LOTUS BLAKE ESTEEM SCOOTER

K103771 is an FDA 510(k) clearance for LOTUS BLAKE ESTEEM SCOOTER, manufactured by Letrix Power Hangzhou Pty, Ltd.. The device is a Class 2 Physical Medicine device with product code INI cleared through the Traditional 510(k) pathway after a 130-day FDA review.

K103771 · Letrix Power Hangzhou Pty, Ltd. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2011
Decision
130d
Days
Class 2
Risk

K103771 is an FDA 510(k) clearance for the LOTUS BLAKE ESTEEM SCOOTER. Classified as Vehicle, Motorized 3-wheeled (product code INI), Class II - Special Controls.

Submitted by Letrix Power Hangzhou Pty, Ltd. (Garden Grove, US). The FDA issued a Cleared decision on May 6, 2011 after a review of 130 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 Letrix Power Hangzhou Pty, Ltd. devices

FDA 510(k) Submission Details - K103771

510(k) Number K103771 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 2010
Decision Date May 06, 2011
Days to Decision 130 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
15d slower than avg
Panel avg: 115d · This submission: 130d
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 163
Devices cleared under the same product code (INI) and FDA review panel - the closest regulatory comparables to K103771.
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