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FDA 510(k)

HOME HEALTH POWER WHEELCHAIR, MODEL HC-200

K-Number: K042719 · 2005-02-03

ApplicantHome Health Technology Co., Ltd.
Decision Date2005-02-03
Product CodeITI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

HOME HEALTH POWER WHEELCHAIR, MODEL HC-200 is the device name listed in this FDA 510(k) record. The listed applicant is Home Health Technology Co., Ltd.. It received FDA 510(k) clearance on 2005-02-03 under 510(k) number K042719. 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 HOME HEALTH POWER WHEELCHAIR, MODEL HC-200?

HOME HEALTH POWER WHEELCHAIR, MODEL HC-200 is a medical device that received FDA 510(k) clearance on 2005-02-03. The listed applicant is Home Health Technology Co., Ltd.. The 510(k) number is K042719.

When did HOME HEALTH POWER WHEELCHAIR, MODEL HC-200 receive FDA 510(k) clearance?

HOME HEALTH POWER WHEELCHAIR, MODEL HC-200 received FDA 510(k) clearance on 2005-02-03, under 510(k) number K042719.

Who is the listed applicant for HOME HEALTH POWER WHEELCHAIR, MODEL HC-200?

The FDA 510(k) record lists Home Health Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HOME HEALTH POWER WHEELCHAIR, MODEL HC-200?

The FDA product code for HOME HEALTH POWER WHEELCHAIR, MODEL HC-200 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 Home Health Technology 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.

K043376HOME HEALTH POWER WHEELCHAIR, MODEL HC-200TR

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

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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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