FDA 510(k)

IKON 40 Manual Wheelchair

K-Number: K190550 · 2019-07-01

Decision Date2019-07-01

Product CodeIOR

Advisory CommitteePM

DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

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. It is manufactured by Broda Seating (Broda Lp). The 510(k) number is K190550.

When was IKON 40 Manual Wheelchair approved by the FDA?

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

What company makes IKON 40 Manual Wheelchair?

IKON 40 Manual Wheelchair is manufactured by Broda Seating (Broda Lp).

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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Related Devices (Code: IOR)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.