FDA 510(k)

Magnesium alloy scooter (RS100)

Número K: K250533 · 2025-05-14

RequerenteTaizhou Reach Technology Co., Ltd.

Data da decisão2025-05-14

Código do produtoINI

Comité consultivoPM

DecisãoSubstantially Equivalent

Resumo do dispositivo

Magnesium alloy scooter (RS100) is the device name listed in this FDA 510(k) record. The listed applicant is Taizhou Reach Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-05-14 under 510(k) number K250533. The device is classified under product code INI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Magnesium alloy scooter (RS100)?

Magnesium alloy scooter (RS100) is a medical device that received FDA 510(k) clearance on 2025-05-14. The listed applicant is Taizhou Reach Technology Co., Ltd.. The 510(k) number is K250533.

When did Magnesium alloy scooter (RS100) receive FDA 510(k) clearance?

Magnesium alloy scooter (RS100) received FDA 510(k) clearance on 2025-05-14, under 510(k) number K250533.

Who is the listed applicant for Magnesium alloy scooter (RS100)?

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

What is the FDA product code for Magnesium alloy scooter (RS100)?

The FDA product code for Magnesium alloy scooter (RS100) is INI.

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