Cleared Special

K011751 - TRAVEL EASE ELECTRIC SCOOTER, MODEL PIONEER 3 (FDA 510(k) Clearance)

Class II Physical Medicine device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K011751 · Merits Health Products., Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2001
Decision
61d
Days
Class 2
Risk

K011751 is an FDA 510(k) clearance for the TRAVEL EASE ELECTRIC SCOOTER, MODEL PIONEER 3. 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 6, 2001 after a review of 61 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

Submission Details

510(k) Number K011751 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 06, 2001
Decision Date August 06, 2001
Days to Decision 61 days
Submission Type Special
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
54d faster than avg
Panel avg: 115d · This submission: 61d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 343
Devices cleared under the same product code (INI) and FDA review panel - the closest regulatory comparables to K011751.
Mobility Scooter (X-12, X-14, X-17)
K260237 · Wuyi Aichi Industry and Trade Co., Ltd. · Apr 2026
Electrical Scooter (SM4226)
K252813 · Lerado Zhongshan Peaceful Cove Business Trading Co., Ltd. · Mar 2026
Power Mobility Scooter (MJMA01, MJMA02)
K253936 · Nanjing Mijo Technology Co., Ltd. · Mar 2026
Mobility Scooter (CL-Q3, CL-Q4)
K253631 · Zhejiang Wei Ling New Energy Technology Co., Ltd. · Feb 2026
Mobility Scooter (S3)
K253643 · Shenzhen Zhimahuaerkai Technology Co., Ltd. · Feb 2026
Electric Scooter (DDF100)
K252275 · Zhejiang Nysin Medical Co., Ltd. · Jan 2026