Cleared Traditional

K001835 - IRV2000 INDIVIDUAL RECREATIONAL VEHICLE

K001835 is an FDA 510(k) clearance for IRV2000 INDIVIDUAL RECREATIONAL VEHICLE, manufactured by Trac About, Inc.. The device is a Class 2 Physical Medicine device with product code INI cleared through the Traditional 510(k) pathway after a 117-day FDA review.

K001835 · Trac About, Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2000
Decision
117d
Days
Class 2
Risk

K001835 is an FDA 510(k) clearance for the IRV2000 INDIVIDUAL RECREATIONAL VEHICLE. Classified as Vehicle, Motorized 3-wheeled (product code INI), Class II - Special Controls.

Submitted by Trac About, Inc. (Lakewood, US). The FDA issued a Cleared decision on October 11, 2000 after a review of 117 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.

FDA 510(k) Submission Details - K001835

510(k) Number K001835 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 2000
Decision Date October 11, 2000
Days to Decision 117 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
1d slower than avg
Panel avg: 116d · This submission: 117d
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 354
Devices cleared under the same product code (INI) and FDA review panel - the closest regulatory comparables to K001835.
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
TRAVEL EASE ELECTRIC SCOOTER, MODEL PIONEER
K003815 · Merits Health Products., Inc. · Dec 2000
ELECTRIC MOBILITY RASCAL AND CHAUFFER SCOOTERS
K002616 · Electric Mobility Corp. · Dec 2000
C.T.M. MOBILITY SCOOTERS HS-666, HS-730, HS-570
K000354 · Warepalmy Enterprise, LLC (Usa) · Aug 2000
C.T.M. MOBILITY SCOOTER, MODEL H2-686, HS-740, HS-580
K000356 · Warepalmy Enterprise, LLC (Usa) · Aug 2000
LA PERSONAL SCOOTER
K000869 · Assembled Products Corp. · Jul 2000
K001835 · IRV2000 INDIVIDUAL RECREATIONAL VEHICLE
Download PDF Trac About, Inc.