Cleared Traditional

K051473 - LEARDO, AVANTICARE ELECTRICAL SCOOTERSM3021

K051473 is an FDA 510(k) clearance for LEARDO, manufactured by Lerado China Limited. The device is a Class 2 Physical Medicine device with product code INI cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K051473 · Lerado China Limited · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2005
Decision
89d
Days
Class 2
Risk

K051473 is an FDA 510(k) clearance for the LEARDO, AVANTICARE ELECTRICAL SCOOTERSM3021. Classified as Vehicle, Motorized 3-wheeled (product code INI), Class II - Special Controls.

Submitted by Lerado China Limited (Hsin-Chu City, TW). The FDA issued a Cleared decision on August 31, 2005 after a review of 89 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K051473

510(k) Number K051473 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 2005
Decision Date August 31, 2005
Days to Decision 89 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
27d faster than avg
Panel avg: 116d · This submission: 89d
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 351
Devices cleared under the same product code (INI) and FDA review panel - the closest regulatory comparables to K051473.
PROASIA, MODEL L3402
K052378 · Proasia Limited · Oct 2005
PROASIA, MODEL L4501
K052486 · Proasia Limited · Oct 2005
VCS S3Y
K051130 · Cycling and Health Tech. Industry R&D Center/Chc · Sep 2005
VCS S3T
K051131 · Cycling and Health Tech. Industry R&D Center/Chc · Aug 2005
AVANTICARE, MODEL SA4022
K051538 · Lerado China Limited · Jul 2005
SMARTECH, MODEL HOLI I
K050507 · Cycling and Health Tech. Industry R&D Center · Jul 2005
K051473 · LEARDO, AVANTICARE ELECTRICAL SCOOTERSM3021
Download PDF FDA Summary Lerado China Limited