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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 a medical device manufactured by Rollz International BV. It received FDA 510(k) clearance on 2025-11-07 under approval 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. It is manufactured by Rollz International BV. The 510(k) number is K250819.

When was Electric Wheelchair (Rollz Motion Electric 2M) approved by the FDA?

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

What company makes Electric Wheelchair (Rollz Motion Electric 2M)?

Electric Wheelchair (Rollz Motion Electric 2M) is manufactured by Rollz International BV.

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.

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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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