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FDA 510(k)

A&I POWER WHEELCHAIR, PC-401

K-Number: K041190 · 2004-05-25

ApplicantWell Success Biotech, Inc.
Decision Date2004-05-25
Product CodeITI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

A&I POWER WHEELCHAIR, PC-401 is the device name listed in this FDA 510(k) record. The listed applicant is Well Success Biotech, Inc.. It received FDA 510(k) clearance on 2004-05-25 under 510(k) number K041190. The device is classified under product code ITI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the A&I POWER WHEELCHAIR, PC-401?

A&I POWER WHEELCHAIR, PC-401 is a medical device that received FDA 510(k) clearance on 2004-05-25. The listed applicant is Well Success Biotech, Inc.. The 510(k) number is K041190.

When did A&I POWER WHEELCHAIR, PC-401 receive FDA 510(k) clearance?

A&I POWER WHEELCHAIR, PC-401 received FDA 510(k) clearance on 2004-05-25, under 510(k) number K041190.

Who is the listed applicant for A&I POWER WHEELCHAIR, PC-401?

The FDA 510(k) record lists Well Success Biotech, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for A&I POWER WHEELCHAIR, PC-401?

The FDA product code for A&I POWER WHEELCHAIR, PC-401 is ITI.

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 Well Success Biotech, 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.

K041187A&I SCOOTER, SC-301K041193A&I SCOOTER, SC-402

Related Devices (Code: ITI)

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.

K262582Electric wheelchair (GP100)Suzhou Green Pine Medical Co., Ltd.K262054Electric WheelchairYongkang Joymax Medical Technology Co., Ltd.K260053Power Wheelchair (OS-R-M01I)Beijing OrionStar Technology Co., Ltd.K260229Electric wheelchair (HC819N, HC830N, HC831N)Yongkang Hengyi Vehicle Co., Ltd.K261354Electric wheelchair (D03)Foshan Sowell Medical Technology Co., Ltd.K261149Electric Wheelchair (DY611A-2, DY612A-1)Zhejiang Lumbre Electric Appliance 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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