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FDA 510(k)

HERO 1, MODEL LY-ESB220

K-Number: K031621 · 2004-01-22

ApplicantComfort Orthopedic Co., Ltd.
Decision Date2004-01-22
Product CodeIPL
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

HERO 1, MODEL LY-ESB220 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 2004-01-22 under 510(k) number K031621. The device is classified under product code IPL. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HERO 1, MODEL LY-ESB220?

HERO 1, MODEL LY-ESB220 is a medical device that received FDA 510(k) clearance on 2004-01-22. The listed applicant is Comfort Orthopedic Co., Ltd.. The 510(k) number is K031621.

When did HERO 1, MODEL LY-ESB220 receive FDA 510(k) clearance?

HERO 1, MODEL LY-ESB220 received FDA 510(k) clearance on 2004-01-22, under 510(k) number K031621.

Who is the listed applicant for HERO 1, MODEL LY-ESB220?

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 HERO 1, MODEL LY-ESB220?

The FDA product code for HERO 1, MODEL LY-ESB220 is IPL.

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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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