FDA 510(k)

Electric Wheelchair (Rollz Motion Electric 2M)

K-번호: K250819 · 2025-11-07

결정일2025-11-07

제품 코드ITI

자문 위원회PM

결정Substantially Equivalent

기기 요약

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.

자주 묻는 질문

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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Electric Wheelchair (Rollz Motion Electric 2M)

기기 요약

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관련 임상시험

관련 기기 (코드: ITI)

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