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FDA 510(k)

Wheelchair

K-Number: K163352 · 2017-07-28

ApplicantKunshan Hi-Fortune Health Products Co., Ltd.
Decision Date2017-07-28
Product CodeIOR
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Wheelchair is the device name listed in this FDA 510(k) record. The listed applicant is Kunshan Hi-Fortune Health Products Co., Ltd.. It received FDA 510(k) clearance on 2017-07-28 under 510(k) number K163352. 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 Wheelchair?

Wheelchair is a medical device that received FDA 510(k) clearance on 2017-07-28. The listed applicant is Kunshan Hi-Fortune Health Products Co., Ltd.. The 510(k) number is K163352.

When did Wheelchair receive FDA 510(k) clearance?

Wheelchair received FDA 510(k) clearance on 2017-07-28, under 510(k) number K163352.

Who is the listed applicant for Wheelchair?

The FDA 510(k) record lists Kunshan Hi-Fortune Health Products Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Wheelchair?

The FDA product code for Wheelchair is IOR.

Other records listing Kunshan Hi-Fortune Health Products Co., Ltd. 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.

K244003Electrically powered wheelchairK243962Electrically Powered WheelchairK243961Electrically Powered WheelchairK241337Electrically powered wheelchair (HP202)K241632Electrically powered wheelchairK212503HP458E Electrically Powered Wheelchair

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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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