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FDA 510(k)

GEN_2 and GEN_3 Mechanical Wheelchairs

K-Number: K170701 · 2017-03-24

ApplicantFree Wheelchair Mission
Decision Date2017-03-24
Product CodeIOR
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

GEN_2 and GEN_3 Mechanical Wheelchairs is the device name listed in this FDA 510(k) record. The listed applicant is Free Wheelchair Mission. It received FDA 510(k) clearance on 2017-03-24 under 510(k) number K170701. 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 GEN_2 and GEN_3 Mechanical Wheelchairs?

GEN_2 and GEN_3 Mechanical Wheelchairs is a medical device that received FDA 510(k) clearance on 2017-03-24. The listed applicant is Free Wheelchair Mission. The 510(k) number is K170701.

When did GEN_2 and GEN_3 Mechanical Wheelchairs receive FDA 510(k) clearance?

GEN_2 and GEN_3 Mechanical Wheelchairs received FDA 510(k) clearance on 2017-03-24, under 510(k) number K170701.

Who is the listed applicant for GEN_2 and GEN_3 Mechanical Wheelchairs?

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

What is the FDA product code for GEN_2 and GEN_3 Mechanical Wheelchairs?

The FDA product code for GEN_2 and GEN_3 Mechanical Wheelchairs is IOR.

Other records listing Free Wheelchair Mission as applicant

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.

K252370GEN 4 JOY Wheelchair

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

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

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