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FDA 510(k)

DANYANG HUAYI K2 AND K7 WHEELCHAIRS

K-Number: K080207 · 2008-03-12

ApplicantDanyang Huayi Medical Supply & Equipment Co, Ltd.
Decision Date2008-03-12
Product CodeIOR
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

DANYANG HUAYI K2 AND K7 WHEELCHAIRS is the device name listed in this FDA 510(k) record. The listed applicant is Danyang Huayi Medical Supply & Equipment Co, Ltd.. It received FDA 510(k) clearance on 2008-03-12 under 510(k) number K080207. 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 DANYANG HUAYI K2 AND K7 WHEELCHAIRS?

DANYANG HUAYI K2 AND K7 WHEELCHAIRS is a medical device that received FDA 510(k) clearance on 2008-03-12. The listed applicant is Danyang Huayi Medical Supply & Equipment Co, Ltd.. The 510(k) number is K080207.

When did DANYANG HUAYI K2 AND K7 WHEELCHAIRS receive FDA 510(k) clearance?

DANYANG HUAYI K2 AND K7 WHEELCHAIRS received FDA 510(k) clearance on 2008-03-12, under 510(k) number K080207.

Who is the listed applicant for DANYANG HUAYI K2 AND K7 WHEELCHAIRS?

The FDA 510(k) record lists Danyang Huayi Medical Supply & Equipment Co, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DANYANG HUAYI K2 AND K7 WHEELCHAIRS?

The FDA product code for DANYANG HUAYI K2 AND K7 WHEELCHAIRS is IOR.

Related Clinical Trials

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Other records listing Danyang Huayi Medical Supply & Equipment 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.

K091482HUAYI K-SERIES LIGHTWEIGHT WHEELCHAIR K3/K4K080114HUAYI H035 BASIC WHEELCHAIR

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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