Cleared Traditional

K982145 - MEGA 3

K982145 is an FDA 510(k) clearance for MEGA 3, manufactured by Mega Motion, Inc.. The device is a Class 2 Physical Medicine device with product code INI cleared through the Traditional 510(k) pathway after a 301-day FDA review.

K982145 · Mega Motion, Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1999
Decision
301d
Days
Class 2
Risk

K982145 is an FDA 510(k) clearance for the MEGA 3. Classified as Vehicle, Motorized 3-wheeled (product code INI), Class II - Special Controls.

Submitted by Mega Motion, Inc. (Scranton, US). The FDA issued a Cleared decision on April 14, 1999 after a review of 301 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Mega Motion, Inc. devices

FDA 510(k) Submission Details - K982145

510(k) Number K982145 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 1998
Decision Date April 14, 1999
Days to Decision 301 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
186d slower than avg
Panel avg: 115d · This submission: 301d
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 173
Devices cleared under the same product code (INI) and FDA review panel - the closest regulatory comparables to K982145.
MODELS LYNX AND PANTHER MOTORIZED SCOOTERS
K992052 · Invacare Corp. · Aug 1999
AMIGO MODEL 590000
K983987 · Amigo Mobility Intl., Inc. · Jun 1999
MEGA 4
K982144 · Mega Motion, Inc. · Apr 1999
C.T.M. MOBILITY SCOOTER, MODEL # HS-686
K983662 · Warepalmy Enterprise, LLC (Usa) · Dec 1998
C.T.M. MOBILITY SCOOTER, MODEL # HS-666
K983663 · Warepalmy Enterprise, LLC (Usa) · Dec 1998
SUNRISE SCOOTER SERIES, MODEL UNASSIGNED, 3 WHEEL STANDARD MODEL, 3 WHEEL MID RANGE MODEL, 3 WHEEL HIGH END MODEL, 4 WHE
K981885 · Sunrise Medical, Inc. · Nov 1998