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FDA 510(k)

Electric Wheelchair (Rollz Motion Electric 2M)

K-Number: K250819 · 2025-11-07

ApplicantRollz International BV
Decision Date2025-11-07
Product CodeITI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Electric Wheelchair (Rollz Motion Electric 2M) is the device name listed in this FDA 510(k) record. The listed applicant is Rollz International BV. It received FDA 510(k) clearance on 2025-11-07 under 510(k) number K250819. 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 (Rollz Motion Electric 2M)?

Electric Wheelchair (Rollz Motion Electric 2M) is a medical device that received FDA 510(k) clearance on 2025-11-07. The listed applicant is Rollz International BV. The 510(k) number is K250819.

When did Electric Wheelchair (Rollz Motion Electric 2M) receive FDA 510(k) clearance?

Electric Wheelchair (Rollz Motion Electric 2M) received FDA 510(k) clearance on 2025-11-07, under 510(k) number K250819.

Who is the listed applicant for Electric Wheelchair (Rollz Motion Electric 2M)?

The FDA 510(k) record lists Rollz International BV as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Electric Wheelchair (Rollz Motion Electric 2M)?

The FDA product code for Electric Wheelchair (Rollz Motion Electric 2M) 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.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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