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FDA 510(k)

RGK Daily Range Wheelchairs

K-Number: K200135 · 2020-09-10

ApplicantRgk Wheelchairs, Ltd.
Decision Date2020-09-10
Product CodeIOR
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

RGK Daily Range Wheelchairs is the device name listed in this FDA 510(k) record. The listed applicant is Rgk Wheelchairs, Ltd.. It received FDA 510(k) clearance on 2020-09-10 under 510(k) number K200135. 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 RGK Daily Range Wheelchairs?

RGK Daily Range Wheelchairs is a medical device that received FDA 510(k) clearance on 2020-09-10. The listed applicant is Rgk Wheelchairs, Ltd.. The 510(k) number is K200135.

When did RGK Daily Range Wheelchairs receive FDA 510(k) clearance?

RGK Daily Range Wheelchairs received FDA 510(k) clearance on 2020-09-10, under 510(k) number K200135.

Who is the listed applicant for RGK Daily Range Wheelchairs?

The FDA 510(k) record lists Rgk Wheelchairs, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RGK Daily Range Wheelchairs?

The FDA product code for RGK Daily Range Wheelchairs 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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