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FDA 510(k)

COMFORT STANDING WHEELCHAIR, HERO SERIES

K-Number: K102734 · 2010-12-14

ApplicantComfort Orthopedic Co., Ltd.
Decision Date2010-12-14
Product CodeIPL
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

COMFORT STANDING WHEELCHAIR, HERO SERIES 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 2010-12-14 under 510(k) number K102734. 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 COMFORT STANDING WHEELCHAIR, HERO SERIES?

COMFORT STANDING WHEELCHAIR, HERO SERIES is a medical device that received FDA 510(k) clearance on 2010-12-14. The listed applicant is Comfort Orthopedic Co., Ltd.. The 510(k) number is K102734.

When did COMFORT STANDING WHEELCHAIR, HERO SERIES receive FDA 510(k) clearance?

COMFORT STANDING WHEELCHAIR, HERO SERIES received FDA 510(k) clearance on 2010-12-14, under 510(k) number K102734.

Who is the listed applicant for COMFORT STANDING WHEELCHAIR, HERO SERIES?

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 STANDING WHEELCHAIR, HERO SERIES?

The FDA product code for COMFORT STANDING WHEELCHAIR, HERO SERIES is IPL.

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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: IPL)

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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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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