Lite

FDA 510(k) K172409 · Tzora Active Systems , Ltd.

Substantially Equivalent

510(k) numberK172409

Submission

Device name
Lite
Applicant
Tzora Active Systems , Ltd.
Kibbutz Tzora, IL
Received
August 9, 2017
Decision date
May 2, 2018
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 Lite cleared by the FDA?

Lite (K172409) received a 510(k) decision of Substantially Equivalent on May 2, 2018, 266 days after the submission was received.

What is the product code of K172409?

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