FDA 510(k)

Cadeira de Rodas Elétrica, Joy Rider

Número K: K220156 · 2022-10-07

RequerenteTung Keng Enterprise Co., Ltd.

Data da decisão2022-10-07

Código do produtoITI

Comité consultivoPM

DecisãoSubstantially Equivalent

Resumo do dispositivo

Electrically Powered Wheelchair, Joy Rider is the device name listed in this FDA 510(k) record. The listed applicant is Tung Keng Enterprise Co., Ltd.. It received FDA 510(k) clearance on 2022-10-07 under 510(k) number K220156. 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 Electrically Powered Wheelchair, Joy Rider?

Electrically Powered Wheelchair, Joy Rider is a medical device that received FDA 510(k) clearance on 2022-10-07. The listed applicant is Tung Keng Enterprise Co., Ltd.. The 510(k) number is K220156.

When did Electrically Powered Wheelchair, Joy Rider receive FDA 510(k) clearance?

Electrically Powered Wheelchair, Joy Rider received FDA 510(k) clearance on 2022-10-07, under 510(k) number K220156.

Who is the listed applicant for Electrically Powered Wheelchair, Joy Rider?

The FDA 510(k) record lists Tung Keng Enterprise Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Electrically Powered Wheelchair, Joy Rider?

The FDA product code for Electrically Powered Wheelchair, Joy Rider is ITI.

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