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FDA 510(k)

HP458E Electrically Powered Wheelchair

K-Number: K212503 · 2022-01-18

ApplicantKunshan Hi-Fortune Health Products Co., Ltd.
Decision Date2022-01-18
Product CodeITI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

HP458E Electrically Powered Wheelchair 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 2022-01-18 under 510(k) number K212503. 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 HP458E Electrically Powered Wheelchair?

HP458E Electrically Powered Wheelchair is a medical device that received FDA 510(k) clearance on 2022-01-18. The listed applicant is Kunshan Hi-Fortune Health Products Co., Ltd.. The 510(k) number is K212503.

When did HP458E Electrically Powered Wheelchair receive FDA 510(k) clearance?

HP458E Electrically Powered Wheelchair received FDA 510(k) clearance on 2022-01-18, under 510(k) number K212503.

Who is the listed applicant for HP458E Electrically Powered Wheelchair?

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 HP458E Electrically Powered Wheelchair?

The FDA product code for HP458E Electrically Powered Wheelchair 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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