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FDA 510(k)

Electrically Powered Wheelchair -Model HP358E

K-Number: K201855 · 2021-09-28

ApplicantKunshan Hi-Fortune Health Products Co., Ltd.
Decision Date2021-09-28
Product CodeITI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Electrically Powered Wheelchair -Model HP358E is the device name listed in this FDA 510(k) record. The listed applicant is Kunshan Hi-Fortune Health Products Co., Ltd.. It received FDA 510(k) clearance on 2021-09-28 under 510(k) number K201855. 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 Electrically Powered Wheelchair -Model HP358E?

Electrically Powered Wheelchair -Model HP358E is a medical device that received FDA 510(k) clearance on 2021-09-28. The listed applicant is Kunshan Hi-Fortune Health Products Co., Ltd.. The 510(k) number is K201855.

When did Electrically Powered Wheelchair -Model HP358E receive FDA 510(k) clearance?

Electrically Powered Wheelchair -Model HP358E received FDA 510(k) clearance on 2021-09-28, under 510(k) number K201855.

Who is the listed applicant for Electrically Powered Wheelchair -Model HP358E?

The FDA 510(k) record lists Kunshan Hi-Fortune Health Products Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Electrically Powered Wheelchair -Model HP358E?

The FDA product code for Electrically Powered Wheelchair -Model HP358E is ITI.

Other records listing Kunshan Hi-Fortune Health Products Co., Ltd. as applicant

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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.

K261149Electric Wheelchair (DY611A-2, DY612A-1)Zhejiang Lumbre Electric Appliance Co., Ltd.K261396Electric WheelchairNingbo Resshidi Medical Devices Co., Ltd.K261164Electric wheelchair (XW-LY007 )Yongkang Ruihe Metal Product Co., Ltd.K260937Smart Electric Wheelchair (R1-Std-BK, R1-Pro-BK, R1-Ultra-GK, R1-Ultra-WK)Shanghai Waylong Intelligent Technology Co.,LtdK253812Power Wheelchair (W5915B, W5915C, W5915D)Zhejiang Innuovo Rehabilitation Devices Co.,LtdK260335Electric Wheelchair (S500-6)Zhongshan Sulenz Intelligent Technology 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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