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FDA 510(k)

COMFORT AGILE SCOOTER, LY-EW303

K-Number: K023581 · 2002-12-02

ApplicantComfort Orthopedic Co., Ltd.
Decision Date2002-12-02
Product CodeINI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

COMFORT AGILE SCOOTER, LY-EW303 is the device name listed in this FDA 510(k) record. The listed applicant is Comfort Orthopedic Co., Ltd.. It received FDA 510(k) clearance on 2002-12-02 under 510(k) number K023581. 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 COMFORT AGILE SCOOTER, LY-EW303?

COMFORT AGILE SCOOTER, LY-EW303 is a medical device that received FDA 510(k) clearance on 2002-12-02. The listed applicant is Comfort Orthopedic Co., Ltd.. The 510(k) number is K023581.

When did COMFORT AGILE SCOOTER, LY-EW303 receive FDA 510(k) clearance?

COMFORT AGILE SCOOTER, LY-EW303 received FDA 510(k) clearance on 2002-12-02, under 510(k) number K023581.

Who is the listed applicant for COMFORT AGILE SCOOTER, LY-EW303?

The FDA 510(k) record lists Comfort Orthopedic Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COMFORT AGILE SCOOTER, LY-EW303?

The FDA product code for COMFORT AGILE SCOOTER, LY-EW303 is INI.

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Other records listing Comfort Orthopedic Co., Ltd. as applicant

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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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