FDA 510(k)

IKON 40 Manual Wheelchair

Número K: K190550 · 2019-07-01

Data da decisão2019-07-01

Código do produtoIOR

Comité consultivoPM

DecisãoSubstantially Equivalent

Resumo do dispositivo

IKON 40 Manual Wheelchair is the device name listed in this FDA 510(k) record. The listed applicant is Broda Seating (Broda Lp). It received FDA 510(k) clearance on 2019-07-01 under 510(k) number K190550. The device is classified under product code IOR. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the IKON 40 Manual Wheelchair?

IKON 40 Manual Wheelchair is a medical device that received FDA 510(k) clearance on 2019-07-01. The listed applicant is Broda Seating (Broda Lp). The 510(k) number is K190550.

When did IKON 40 Manual Wheelchair receive FDA 510(k) clearance?

IKON 40 Manual Wheelchair received FDA 510(k) clearance on 2019-07-01, under 510(k) number K190550.

Who is the listed applicant for IKON 40 Manual Wheelchair?

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

What is the FDA product code for IKON 40 Manual Wheelchair?

The FDA product code for IKON 40 Manual Wheelchair is IOR.

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