FDA 510(k)

Luggie Chair

Número K: K160139 · 2017-03-20

Data da decisão2017-03-20

Código do produtoITI

Comité consultivoPM

DecisãoSubstantially Equivalent

Resumo do dispositivo

Luggie Chair is the device name listed in this FDA 510(k) record. The listed applicant is Freerider Corporation. It received FDA 510(k) clearance on 2017-03-20 under 510(k) number K160139. 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 Luggie Chair?

Luggie Chair is a medical device that received FDA 510(k) clearance on 2017-03-20. The listed applicant is Freerider Corporation. The 510(k) number is K160139.

When did Luggie Chair receive FDA 510(k) clearance?

Luggie Chair received FDA 510(k) clearance on 2017-03-20, under 510(k) number K160139.

Who is the listed applicant for Luggie Chair?

The FDA 510(k) record lists Freerider Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Luggie Chair?

The FDA product code for Luggie Chair is ITI.

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