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FDA 510(k)

MERLEXI CRAFT SERIES OF MANUAL (MECHANICAL) WHEELCHAIRS

K-Number: K032731 · 2003-10-30

ApplicantTurbo Wheelchair Co., Inc.
Decision Date2003-10-30
Product CodeIOR
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

MERLEXI CRAFT SERIES OF MANUAL (MECHANICAL) WHEELCHAIRS is the device name listed in this FDA 510(k) record. The listed applicant is Turbo Wheelchair Co., Inc.. It received FDA 510(k) clearance on 2003-10-30 under 510(k) number K032731. 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 MERLEXI CRAFT SERIES OF MANUAL (MECHANICAL) WHEELCHAIRS?

MERLEXI CRAFT SERIES OF MANUAL (MECHANICAL) WHEELCHAIRS is a medical device that received FDA 510(k) clearance on 2003-10-30. The listed applicant is Turbo Wheelchair Co., Inc.. The 510(k) number is K032731.

When did MERLEXI CRAFT SERIES OF MANUAL (MECHANICAL) WHEELCHAIRS receive FDA 510(k) clearance?

MERLEXI CRAFT SERIES OF MANUAL (MECHANICAL) WHEELCHAIRS received FDA 510(k) clearance on 2003-10-30, under 510(k) number K032731.

Who is the listed applicant for MERLEXI CRAFT SERIES OF MANUAL (MECHANICAL) WHEELCHAIRS?

The FDA 510(k) record lists Turbo Wheelchair Co., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MERLEXI CRAFT SERIES OF MANUAL (MECHANICAL) WHEELCHAIRS?

The FDA product code for MERLEXI CRAFT SERIES OF MANUAL (MECHANICAL) WHEELCHAIRS 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 Turbo Wheelchair Co., Inc. 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.

K240120Merlexi Craft Bariatric series of manual 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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