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FDA 510(k)

Wu's Powered Wheelchair

K-Number: K181163 · 2019-02-16

ApplicantWu'S Tech Co., Ltd.
Decision Date2019-02-16
Product CodeITI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Wu's Powered Wheelchair is the device name listed in this FDA 510(k) record. The listed applicant is Wu'S Tech Co., Ltd.. It received FDA 510(k) clearance on 2019-02-16 under 510(k) number K181163. 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 Wu's Powered Wheelchair?

Wu's Powered Wheelchair is a medical device that received FDA 510(k) clearance on 2019-02-16. The listed applicant is Wu'S Tech Co., Ltd.. The 510(k) number is K181163.

When did Wu's Powered Wheelchair receive FDA 510(k) clearance?

Wu's Powered Wheelchair received FDA 510(k) clearance on 2019-02-16, under 510(k) number K181163.

Who is the listed applicant for Wu's Powered Wheelchair?

The FDA 510(k) record lists Wu'S Tech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Wu's Powered Wheelchair?

The FDA product code for Wu's Powered Wheelchair is ITI.

Other records listing Wu'S Tech 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.

K222729Electrical Scooter, WT-T4QP2K192308Wu's Electrical Scooter

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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