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FDA 510(k)

Smart Electric Wheelchair (R1-Std-BK, R1-Pro-BK, R1-Ultra-GK, R1-Ultra-WK)

K-Number: K260937 · 2026-06-24

ApplicantShanghai Waylong Intelligent Technology Co.,Ltd
Decision Date2026-06-24
Product CodeITI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Smart Electric Wheelchair (R1-Std-BK, R1-Pro-BK, R1-Ultra-GK, R1-Ultra-WK) is the device name listed in this FDA 510(k) record. The listed applicant is Shanghai Waylong Intelligent Technology Co.,Ltd. It received FDA 510(k) clearance on 2026-06-24 under 510(k) number K260937. 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 Smart Electric Wheelchair (R1-Std-BK, R1-Pro-BK, R1-Ultra-GK, R1-Ultra-WK)?

Smart Electric Wheelchair (R1-Std-BK, R1-Pro-BK, R1-Ultra-GK, R1-Ultra-WK) is a medical device that received FDA 510(k) clearance on 2026-06-24. The listed applicant is Shanghai Waylong Intelligent Technology Co.,Ltd. The 510(k) number is K260937.

When did Smart Electric Wheelchair (R1-Std-BK, R1-Pro-BK, R1-Ultra-GK, R1-Ultra-WK) receive FDA 510(k) clearance?

Smart Electric Wheelchair (R1-Std-BK, R1-Pro-BK, R1-Ultra-GK, R1-Ultra-WK) received FDA 510(k) clearance on 2026-06-24, under 510(k) number K260937.

Who is the listed applicant for Smart Electric Wheelchair (R1-Std-BK, R1-Pro-BK, R1-Ultra-GK, R1-Ultra-WK)?

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

What is the FDA product code for Smart Electric Wheelchair (R1-Std-BK, R1-Pro-BK, R1-Ultra-GK, R1-Ultra-WK)?

The FDA product code for Smart Electric Wheelchair (R1-Std-BK, R1-Pro-BK, R1-Ultra-GK, R1-Ultra-WK) is ITI.

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.K253812Power Wheelchair (W5915B, W5915C, W5915D)Zhejiang Innuovo Rehabilitation Devices Co.,LtdK260335Electric Wheelchair (S500-6)Zhongshan Sulenz Intelligent Technology Co., Ltd.K261175WHILL (WHILL Model C2)Whill, Inc.

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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