Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Winner Transfer Wheelchair

K-Number: K162328 · 2017-05-11

ApplicantWinner SG Pte, Ltd.
Decision Date2017-05-11
Product CodeIOR
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Winner Transfer Wheelchair is the device name listed in this FDA 510(k) record. The listed applicant is Winner SG Pte, Ltd.. It received FDA 510(k) clearance on 2017-05-11 under 510(k) number K162328. 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 Winner Transfer Wheelchair?

Winner Transfer Wheelchair is a medical device that received FDA 510(k) clearance on 2017-05-11. The listed applicant is Winner SG Pte, Ltd.. The 510(k) number is K162328.

When did Winner Transfer Wheelchair receive FDA 510(k) clearance?

Winner Transfer Wheelchair received FDA 510(k) clearance on 2017-05-11, under 510(k) number K162328.

Who is the listed applicant for Winner Transfer Wheelchair?

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

What is the FDA product code for Winner Transfer Wheelchair?

The FDA product code for Winner Transfer 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.

↑