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FDA 510(k)

LOTUS BLAKE ESTEEM SCOOTER

K-Number: K103771 · 2011-05-06

ApplicantLetrix Power Hangzhou Pty, Ltd.
Decision Date2011-05-06
Product CodeINI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

LOTUS BLAKE ESTEEM SCOOTER is the device name listed in this FDA 510(k) record. The listed applicant is Letrix Power Hangzhou Pty, Ltd.. It received FDA 510(k) clearance on 2011-05-06 under 510(k) number K103771. 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 LOTUS BLAKE ESTEEM SCOOTER?

LOTUS BLAKE ESTEEM SCOOTER is a medical device that received FDA 510(k) clearance on 2011-05-06. The listed applicant is Letrix Power Hangzhou Pty, Ltd.. The 510(k) number is K103771.

When did LOTUS BLAKE ESTEEM SCOOTER receive FDA 510(k) clearance?

LOTUS BLAKE ESTEEM SCOOTER received FDA 510(k) clearance on 2011-05-06, under 510(k) number K103771.

Who is the listed applicant for LOTUS BLAKE ESTEEM SCOOTER?

The FDA 510(k) record lists Letrix Power Hangzhou Pty, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LOTUS BLAKE ESTEEM SCOOTER?

The FDA product code for LOTUS BLAKE ESTEEM SCOOTER is INI.

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Official Source

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

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