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FDA 510(k)

MAXHEALTH MECHANICAL WHEELCHAIR, K1

K-Number: K070176 · 2007-03-01

ApplicantMaxhealth Corp.
Decision Date2007-03-01
Product CodeIOR
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

MAXHEALTH MECHANICAL WHEELCHAIR, K1 is the device name listed in this FDA 510(k) record. The listed applicant is Maxhealth Corp.. It received FDA 510(k) clearance on 2007-03-01 under 510(k) number K070176. 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 MAXHEALTH MECHANICAL WHEELCHAIR, K1?

MAXHEALTH MECHANICAL WHEELCHAIR, K1 is a medical device that received FDA 510(k) clearance on 2007-03-01. The listed applicant is Maxhealth Corp.. The 510(k) number is K070176.

When did MAXHEALTH MECHANICAL WHEELCHAIR, K1 receive FDA 510(k) clearance?

MAXHEALTH MECHANICAL WHEELCHAIR, K1 received FDA 510(k) clearance on 2007-03-01, under 510(k) number K070176.

Who is the listed applicant for MAXHEALTH MECHANICAL WHEELCHAIR, K1?

The FDA 510(k) record lists Maxhealth Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MAXHEALTH MECHANICAL WHEELCHAIR, K1?

The FDA product code for MAXHEALTH MECHANICAL WHEELCHAIR, K1 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 Maxhealth Corp. 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.

K001252MAXHEALTH WHEELCHAIR, MODEL HE-8631, HE-8621, HE-8651

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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