Cleared Traditional

K060068 - AVANTICARE, MODEL SA4021

K060068 is an FDA 510(k) clearance for AVANTICARE, 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 58-day FDA review.

K060068 · Lerado China Limited · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2006
Decision
58d
Days
Class 2
Risk

K060068 is an FDA 510(k) clearance for the AVANTICARE, MODEL SA4021. Classified as Vehicle, Motorized 3-wheeled (product code INI), Class II - Special Controls.

Submitted by Lerado China Limited (Taichung, TW). The FDA issued a Cleared decision on March 8, 2006 after a review of 58 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 - K060068

510(k) Number K060068 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 09, 2006
Decision Date March 08, 2006
Days to Decision 58 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
58d faster than avg
Panel avg: 116d · This submission: 58d
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
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K060068 · AVANTICARE, MODEL SA4021
Download PDF FDA Summary Lerado China Limited