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FDA 510(k)

COMFORT SCOOTER, MODEL LY-EW415

K-Number: K063032 · 2006-10-16

ApplicantComfort Orthopedic Co., Ltd.
Decision Date2006-10-16
Product CodeINI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

COMFORT SCOOTER, MODEL LY-EW415 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 2006-10-16 under 510(k) number K063032. 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 SCOOTER, MODEL LY-EW415?

COMFORT SCOOTER, MODEL LY-EW415 is a medical device that received FDA 510(k) clearance on 2006-10-16. The listed applicant is Comfort Orthopedic Co., Ltd.. The 510(k) number is K063032.

When did COMFORT SCOOTER, MODEL LY-EW415 receive FDA 510(k) clearance?

COMFORT SCOOTER, MODEL LY-EW415 received FDA 510(k) clearance on 2006-10-16, under 510(k) number K063032.

Who is the listed applicant for COMFORT SCOOTER, MODEL LY-EW415?

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 SCOOTER, MODEL LY-EW415?

The FDA product code for COMFORT SCOOTER, MODEL LY-EW415 is INI.

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

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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