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FDA 510(k)

Scooter

K-Number: K182471 · 2019-07-10

ApplicantTianjin Kepler Vehicle Industry Co. , Ltd.
Decision Date2019-07-10
Product CodeINI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Scooter is a medical device manufactured by Tianjin Kepler Vehicle Industry Co. , Ltd.. It received FDA 510(k) clearance on 2019-07-10 under approval number K182471. The device is classified under product code INI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Scooter?

Scooter is a medical device that received FDA 510(k) clearance on 2019-07-10. It is manufactured by Tianjin Kepler Vehicle Industry Co. , Ltd.. The 510(k) number is K182471.

When was Scooter approved by the FDA?

Scooter received FDA 510(k) clearance on 2019-07-10, under approval number K182471.

What company makes Scooter?

Scooter is manufactured by Tianjin Kepler Vehicle Industry Co. , Ltd..

What is the FDA product code for Scooter?

The FDA product code for Scooter is INI.

Related Devices (Code: INI)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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