FDA 510(k)

JIANGSU HEALTHY WAY MECHANICAL WHEELCHAIR

K-Number: K112948 · 2012-03-28

ApplicantJiangsu Healthy Way Medical Equipment Co;Ltd

Decision Date2012-03-28

Product CodeIOR

Advisory CommitteePM

DecisionSubstantially Equivalent

Device Summary

JIANGSU HEALTHY WAY MECHANICAL WHEELCHAIR is the device name listed in this FDA 510(k) record. The listed applicant is Jiangsu Healthy Way Medical Equipment Co;Ltd. It received FDA 510(k) clearance on 2012-03-28 under 510(k) number K112948. 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 JIANGSU HEALTHY WAY MECHANICAL WHEELCHAIR?

JIANGSU HEALTHY WAY MECHANICAL WHEELCHAIR is a medical device that received FDA 510(k) clearance on 2012-03-28. The listed applicant is Jiangsu Healthy Way Medical Equipment Co;Ltd. The 510(k) number is K112948.

When did JIANGSU HEALTHY WAY MECHANICAL WHEELCHAIR receive FDA 510(k) clearance?

JIANGSU HEALTHY WAY MECHANICAL WHEELCHAIR received FDA 510(k) clearance on 2012-03-28, under 510(k) number K112948.

Who is the listed applicant for JIANGSU HEALTHY WAY MECHANICAL WHEELCHAIR?

The FDA 510(k) record lists Jiangsu Healthy Way Medical Equipment Co;Ltd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for JIANGSU HEALTHY WAY MECHANICAL WHEELCHAIR?

The FDA product code for JIANGSU HEALTHY WAY MECHANICAL 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Related Devices (Code: IOR)

K253762ErgoSteel (ES0001/696)Strongback Mobility AG C/O Blueaudit GmbH K261919Multifunctional 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.