Cleared Traditional

K061912 - FUSION

K061912 is an FDA 510(k) clearance for FUSION, manufactured by Burke, Inc.. The device is a Class 2 Physical Medicine device with product code INI cleared through the Traditional 510(k) pathway after a 26-day FDA review.

K061912 · Burke, Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2006
Decision
26d
Days
Class 2
Risk

K061912 is an FDA 510(k) clearance for the FUSION. Classified as Vehicle, Motorized 3-wheeled (product code INI), Class II - Special Controls.

Submitted by Burke, Inc. (Kansas City, US). The FDA issued a Cleared decision on August 1, 2006 after a review of 26 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.

View all Burke, Inc. devices

FDA 510(k) Submission Details - K061912

510(k) Number K061912 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 2006
Decision Date August 01, 2006
Days to Decision 26 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
89d faster than avg
Panel avg: 115d · This submission: 26d
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 247
Devices cleared under the same product code (INI) and FDA review panel - the closest regulatory comparables to K061912.
COMFORT SCOOTER, MODEL LY-EW415
K063032 · Comfort Orthopedic Co., Ltd. · Oct 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
TRAVEL PAL (MM-111B) /MEGA MOTION
K060697 · Mega Motion, Inc. · Apr 2006
AVANTICARE, MODEL SA4021
K060068 · Lerado China Limited · Mar 2006
THE ELITE - ULTRA-LIGHT, COMPACT PORTABLE SCOOTER
K052204 · Tzora Active Systems , Ltd. · Feb 2006