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FDA 510(k)

HUAYI K-SERIES LIGHTWEIGHT WHEELCHAIR K3/K4

K-Number: K091482 · 2009-07-06

ApplicantDanyang Huayi Medical Supply & Equipment Co, Ltd.
Decision Date2009-07-06
Product CodeIOR
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

HUAYI K-SERIES LIGHTWEIGHT WHEELCHAIR K3/K4 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 2009-07-06 under 510(k) number K091482. 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 K-SERIES LIGHTWEIGHT WHEELCHAIR K3/K4?

HUAYI K-SERIES LIGHTWEIGHT WHEELCHAIR K3/K4 is a medical device that received FDA 510(k) clearance on 2009-07-06. The listed applicant is Danyang Huayi Medical Supply & Equipment Co, Ltd.. The 510(k) number is K091482.

When did HUAYI K-SERIES LIGHTWEIGHT WHEELCHAIR K3/K4 receive FDA 510(k) clearance?

HUAYI K-SERIES LIGHTWEIGHT WHEELCHAIR K3/K4 received FDA 510(k) clearance on 2009-07-06, under 510(k) number K091482.

Who is the listed applicant for HUAYI K-SERIES LIGHTWEIGHT WHEELCHAIR K3/K4?

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 K-SERIES LIGHTWEIGHT WHEELCHAIR K3/K4?

The FDA product code for HUAYI K-SERIES LIGHTWEIGHT WHEELCHAIR K3/K4 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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.

K080207DANYANG HUAYI K2 AND K7 WHEELCHAIRSK080114HUAYI 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

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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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