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FDA 510(k)

Electric Wheelchair (XW-LY001)

K-Number: K200423 · 2021-09-22

ApplicantYongkang Dingchang Industry & Trade Co., Ltd.
Decision Date2021-09-22
Product CodeITI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Electric Wheelchair (XW-LY001) is the device name listed in this FDA 510(k) record. The listed applicant is Yongkang Dingchang Industry & Trade Co., Ltd.. It received FDA 510(k) clearance on 2021-09-22 under 510(k) number K200423. 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 Electric Wheelchair (XW-LY001)?

Electric Wheelchair (XW-LY001) is a medical device that received FDA 510(k) clearance on 2021-09-22. The listed applicant is Yongkang Dingchang Industry & Trade Co., Ltd.. The 510(k) number is K200423.

When did Electric Wheelchair (XW-LY001) receive FDA 510(k) clearance?

Electric Wheelchair (XW-LY001) received FDA 510(k) clearance on 2021-09-22, under 510(k) number K200423.

Who is the listed applicant for Electric Wheelchair (XW-LY001)?

The FDA 510(k) record lists Yongkang Dingchang Industry & Trade Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Electric Wheelchair (XW-LY001)?

The FDA product code for Electric Wheelchair (XW-LY001) is ITI.

Other records listing Yongkang Dingchang Industry & Trade 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.

K182411Scooter, Model: R-100

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

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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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