Cleared Traditional

K010135 - MODELS LYNX AND PANTHER MOTORIZED SCOOTERS

K010135 is an FDA 510(k) clearance for MODELS LYNX AND PANTHER MOTORIZED SCOOTERS, manufactured by Invacare Corp.. The device is a Class 2 Physical Medicine device with product code INI cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K010135 · Invacare Corp. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2001
Decision
30d
Days
Class 2
Risk

K010135 is an FDA 510(k) clearance for the MODELS LYNX AND PANTHER MOTORIZED SCOOTERS, MODELS LYNX SX-3, LYNX SX-3P, LYN.... Classified as Vehicle, Motorized 3-wheeled (product code INI), Class II - Special Controls.

Submitted by Invacare Corp. (Elyria, US). The FDA issued a Cleared decision on February 16, 2001 after a review of 30 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Invacare Corp. devices

FDA 510(k) Submission Details - K010135

510(k) Number K010135 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 17, 2001
Decision Date February 16, 2001
Days to Decision 30 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
85d faster than avg
Panel avg: 115d · This submission: 30d
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 116
Devices cleared under the same product code (INI) and FDA review panel - the closest regulatory comparables to K010135.
WU'S 3-WHEELED NEO SCOOTER, WT-T3B
K023168 · Wu'S Tech Co., Ltd. · Jan 2003
WU'S 4-WHEELED NEO SCOOTER, WT-L4
K013763 · Wu'S Tech Co., Ltd. · Jul 2002
WU'S 3-WHEELED NEO SCOOTER, WT-M3
K014119 · Wu'S Tech Co., Ltd. · Jul 2002
MODELS LYNX AND PANTHER MOTORIZED SCOOTERS
K992052 · Invacare Corp. · Aug 1999
FORTRESS 1704FS FOUR WHEEL SCOOTER
K922966 · Fortress Scientific , Ltd. · Aug 1992
FORTRESS 1700FS REAR WHEEL DRIVE SCOOTER
K922967 · Fortress Scientific , Ltd. · Aug 1992