Cleared Traditional

K964954 - SUPERLIGHT

K964954 is an FDA 510(k) clearance for SUPERLIGHT, manufactured by Wheelcare Scooters, Inc.. The device is a Class 2 Physical Medicine device with product code INI cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K964954 · Wheelcare Scooters, Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1997
Decision
99d
Days
Class 2
Risk

K964954 is an FDA 510(k) clearance for the SUPERLIGHT. Classified as Vehicle, Motorized 3-wheeled (product code INI), Class II - Special Controls.

Submitted by Wheelcare Scooters, Inc. (Camarillo, US). The FDA issued a Cleared decision on March 20, 1997 after a review of 99 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 Wheelcare Scooters, Inc. devices

FDA 510(k) Submission Details - K964954

510(k) Number K964954 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 11, 1996
Decision Date March 20, 1997
Days to Decision 99 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
16d faster than avg
Panel avg: 115d · This submission: 99d
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 162
Devices cleared under the same product code (INI) and FDA review panel - the closest regulatory comparables to K964954.
PROWLER
K972037 · The Buzzz Corp. · Jul 1997
INTRUDER
K972038 · The Buzzz Corp. · Jul 1997
SOLO
K970523 · Ranger All Season Corp. · Jun 1997
TRAVEL EASE ELECTRIC SCOOTER, MODEL: PIONEER
K952042 · Merits Health Products Co., Ltd. · Mar 1996
EURO SC500
K944940 · Pride Health Care, Inc. · Feb 1996
DYNAMO
K944277 · Pride Health Care, Inc. · Dec 1994