Cleared Traditional

K940334 - AMIGO J-9

K940334 is an FDA 510(k) clearance for AMIGO J-9, 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 113-day FDA review.

K940334 · Amigo Mobility Intl., Inc. · Physical Medicine device
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May 1994
Decision
113d
Days
Class 2
Risk

K940334 is an FDA 510(k) clearance for the AMIGO J-9. 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 May 18, 1994 after a review of 113 days - within the typical 510(k) review window.

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 - K940334

510(k) Number K940334 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received January 25, 1994
Decision Date May 18, 1994
Days to Decision 113 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
2d faster than avg
Panel avg: 115d · This submission: 113d
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
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