FDA 510(k)

Electric Wheelchair (S500-6)

Número K: K260335 · 2026-06-15

RequerenteZhongshan Sulenz Intelligent Technology Co., Ltd.

Data da decisão2026-06-15

Código do produtoITI

Comité consultivoPM

DecisãoSubstantially Equivalent

Resumo do dispositivo

Electric Wheelchair (S500-6) is the device name listed in this FDA 510(k) record. The listed applicant is Zhongshan Sulenz Intelligent Technology Co., Ltd.. It received FDA 510(k) clearance on 2026-06-15 under 510(k) number K260335. 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 (S500-6)?

Electric Wheelchair (S500-6) is a medical device that received FDA 510(k) clearance on 2026-06-15. The listed applicant is Zhongshan Sulenz Intelligent Technology Co., Ltd.. The 510(k) number is K260335.

When did Electric Wheelchair (S500-6) receive FDA 510(k) clearance?

Electric Wheelchair (S500-6) received FDA 510(k) clearance on 2026-06-15, under 510(k) number K260335.

Who is the listed applicant for Electric Wheelchair (S500-6)?

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

What is the FDA product code for Electric Wheelchair (S500-6)?

The FDA product code for Electric Wheelchair (S500-6) is ITI.

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