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FDA 510(k)

IKON 40 Manual Wheelchair

K-Number: K190550 · 2019-07-01

ApplicantBroda Seating (Broda Lp)
Decision Date2019-07-01
Product CodeIOR
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

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.

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. 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.

Related Devices (Code: IOR)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261571Manual Wheelchair (H008, PCK7)Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.K252370GEN 4 JOY WheelchairFree Wheelchair MissionK261076Caregiver-assisted wheelchair (MS02);Caregiver-assisted wheelchair (MA02)GuangDong Yong Yi Rehabilitation Equipment Technology Co., Ltd.K261075Manual Wheelchair (MS01);Manual Wheelchair (MA01)GuangDong Yong Yi Rehabilitation Equipment Technology Co., Ltd.K260849ICON 35; ICON 45; ICON 60; ICON 30FAFRehasense USA, Inc.K260642Manual Wheelchair (LW01108)Anhui Longway Medical Technology Co., Ltd.

Official Source

View on FDA Database →

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

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