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FDA 510(k)

HUAYI H035 BASIC WHEELCHAIR

K-Number: K080114 · 2008-02-15

ApplicantDanyang Huayi Medical Supply & Equipment Co, Ltd.
Decision Date2008-02-15
Product CodeIOR
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

HUAYI H035 BASIC WHEELCHAIR 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 2008-02-15 under 510(k) number K080114. 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 HUAYI H035 BASIC WHEELCHAIR?

HUAYI H035 BASIC WHEELCHAIR is a medical device that received FDA 510(k) clearance on 2008-02-15. The listed applicant is Danyang Huayi Medical Supply & Equipment Co, Ltd.. The 510(k) number is K080114.

When did HUAYI H035 BASIC WHEELCHAIR receive FDA 510(k) clearance?

HUAYI H035 BASIC WHEELCHAIR received FDA 510(k) clearance on 2008-02-15, under 510(k) number K080114.

Who is the listed applicant for HUAYI H035 BASIC WHEELCHAIR?

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 HUAYI H035 BASIC WHEELCHAIR?

The FDA product code for HUAYI H035 BASIC WHEELCHAIR is IOR.

Related Clinical Trials

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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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/K4K080207DANYANG HUAYI K2 AND K7 WHEELCHAIRS

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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