Cleared Special

K011753 - TRAVEL EASE ELECTRIC SCOOTER, MODEL PIONEER 4

K011753 is an FDA 510(k) clearance for TRAVEL EASE ELECTRIC SCOOTER, manufactured by Merits Health Products., Inc.. The device is a Class 2 Physical Medicine device with product code INI cleared through the Special 510(k) pathway after a 58-day FDA review.

K011753 · Merits Health Products., Inc. · Physical Medicine device
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Aug 2001
Decision
58d
Days
Class 2
Risk

K011753 is an FDA 510(k) clearance for the TRAVEL EASE ELECTRIC SCOOTER, MODEL PIONEER 4. Classified as Vehicle, Motorized 3-wheeled (product code INI), Class II - Special Controls.

Submitted by Merits Health Products., Inc. (Cape Coral, US). The FDA issued a Cleared decision on August 3, 2001 after a review of 58 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Merits Health Products., Inc. devices

FDA 510(k) Submission Details - K011753

510(k) Number K011753 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 06, 2001
Decision Date August 03, 2001
Days to Decision 58 days
Submission Type Special
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
58d faster than avg
Panel avg: 116d · This submission: 58d
Pathway characteristics
Modification to existing cleared device.

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 313
Devices cleared under the same product code (INI) and FDA review panel - the closest regulatory comparables to K011753.
EASYTRAVEL
K012592 · Tzora Active Systems , Ltd. · Oct 2001
TRAVEL EASE ELECTRIC SCOOTER, MODEL PIONEER 3
K011751 · Merits Health Products., Inc. · Aug 2001
TRAVEL EASE ELECTRIC SCOOTER MODEL # PIONEER 2
K011707 · Merits Medical Industries Co., Ltd. · Aug 2001
RAMBLER
K011401 · Rambler Mobility, Inc. · Jul 2001
AMIGO WHEELCHAIR
K010503 · Amigo Mobility Intl., Inc. · Jul 2001
MODIFICATION TO SOLO
K011107 · Ranger All Season Corp. · May 2001