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FDA 510(k)

COMED K-SERIES MANUAL WHEELCHAIR

K-Number: K120077 · 2012-05-14

ApplicantDanyang Comed Healthcare Co., Ltd.
Decision Date2012-05-14
Product CodeIOR
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

COMED K-SERIES MANUAL WHEELCHAIR is the device name listed in this FDA 510(k) record. The listed applicant is Danyang Comed Healthcare Co., Ltd.. It received FDA 510(k) clearance on 2012-05-14 under 510(k) number K120077. The device is classified under product code IOR. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COMED K-SERIES MANUAL WHEELCHAIR?

COMED K-SERIES MANUAL WHEELCHAIR is a medical device that received FDA 510(k) clearance on 2012-05-14. The listed applicant is Danyang Comed Healthcare Co., Ltd.. The 510(k) number is K120077.

When did COMED K-SERIES MANUAL WHEELCHAIR receive FDA 510(k) clearance?

COMED K-SERIES MANUAL WHEELCHAIR received FDA 510(k) clearance on 2012-05-14, under 510(k) number K120077.

Who is the listed applicant for COMED K-SERIES MANUAL WHEELCHAIR?

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

What is the FDA product code for COMED K-SERIES MANUAL WHEELCHAIR?

The FDA product code for COMED K-SERIES MANUAL WHEELCHAIR is IOR.

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Related Devices (Code: IOR)

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.

K253762ErgoSteel (ES0001/696)Strongback Mobility AG C/O Blueaudit GmbHK261919Multifunctional wheelchair (YJ-059)Zhenjiang Assure Medical Equipment Co., Ltd.K260141Bariatric Heavy Duty Wheelchair (YJ-010V, YJ-010C)Zhenjiang Assure Medical Equipment Co., Ltd.K260145YJ-K1K2 Wheelchair (YJ-013F)Zhenjiang Assure Medical Equipment Co., Ltd.K260144Reclining wheelchair (YJ-013L)Zhenjiang Assure Medical Equipment Co., Ltd.K261571Manual Wheelchair (H008, PCK7)Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.

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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