FDA 510(k)

Electric Wheelchair (Rollz Motion Electric 2M)

Número K: K250819 · 2025-11-07

Data da decisão2025-11-07

Código do produtoITI

Comité consultivoPM

DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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.

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