Cleared Traditional

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. · Physical Medicine

Feb 2001

Decision

30d

Days

Class 2

Risk

About This 510(k) Submission

K010135 is an FDA 510(k) clearance for the MODELS LYNX AND PANTHER MOTORIZED SCOOTERS, MODELS LYNX SX-3, LYNX SX-3P, LYNX LX-3, LYNX LX-3, PANTHER LX-4, a Vehicle, Motorized 3-wheeled (Class II — Special Controls, product code INI), submitted by Invacare Corp. (Elyria, US). The FDA issued a Cleared decision on February 16, 2001, 30 days after receiving the submission on January 17, 2001. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.3800.

Submission Details

510(k) Number	K010135 FDA.gov
FDA Decision	Cleared 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