Cleared Traditional

K983987 - AMIGO MODEL 590000

K983987 is an FDA 510(k) clearance for AMIGO MODEL 590000, manufactured by Amigo Mobility Intl., Inc.. The device is a Class 2 Physical Medicine device with product code INI cleared through the Traditional 510(k) pathway after a 211-day FDA review.

K983987 · Amigo Mobility Intl., Inc. · Physical Medicine device
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Jun 1999
Decision
211d
Days
Class 2
Risk

K983987 is an FDA 510(k) clearance for the AMIGO MODEL 590000. Classified as Vehicle, Motorized 3-wheeled (product code INI), Class II - Special Controls.

Submitted by Amigo Mobility Intl., Inc. (Bridgeport, US). The FDA issued a Cleared decision on June 8, 1999 after a review of 211 days - an extended review 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: 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 Amigo Mobility Intl., Inc. devices

FDA 510(k) Submission Details - K983987

510(k) Number K983987 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 1998
Decision Date June 08, 1999
Days to Decision 211 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
96d slower than avg
Panel avg: 115d · This submission: 211d
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 K983987.
MODELS LYNX AND PANTHER MOTORIZED SCOOTERS, MODELS LYNX SX-3, LYNX SX-3P, LYNX LX-3, LYNX LX-3, PANTHER LX-4
K010135 · Invacare Corp. · Feb 2001
ACTIVA
K991132 · Hoveround Corp. · Oct 1999
MODELS LYNX AND PANTHER MOTORIZED SCOOTERS
K992052 · Invacare Corp. · Aug 1999
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
SAFARI
K970646 · Ranger All Season Corp. · Aug 1997
GOLDEN EAGLE
K971043 · Golden Technologies, Inc. · Aug 1997