Karma Scooter, Model KS-747.2

FDA 510(k) K041677 · Karma Medical Products Co., Ltd.

Substantially Equivalent

510(k) numberK041677

Submission

Device name
Karma Scooter, Model KS-747.2
Applicant
Karma Medical Products Co., Ltd.
Hsin Chu City, TW
Received
June 21, 2004
Decision date
August 5, 2004
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
INI – Vehicle, Motorized 3-Wheeled
Device class
Class II (moderate risk)
Regulation
21 CFR 890.3800
Specialty
Physical Medicine

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Questions and answers

When was Karma Scooter, Model KS-747.2 cleared by the FDA?

Karma Scooter, Model KS-747.2 (K041677) received a 510(k) decision of Substantially Equivalent on August 5, 2004, 45 days after the submission was received.

What is the product code of K041677?

The FDA product code is INI – Vehicle, Motorized 3-Wheeled, a Class II (moderate risk) device regulated under 21 CFR 890.3800.