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FDA 510(k)

SUNCO Mechanical Wheelchair, model SKW-9003

K-Number: K153328 · 2016-07-20

ApplicantDanyang Sunco Machinery Co., Ltd.
Decision Date2016-07-20
Product CodeIOR
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

SUNCO Mechanical Wheelchair, model SKW-9003 is the device name listed in this FDA 510(k) record. The listed applicant is Danyang Sunco Machinery Co., Ltd.. It received FDA 510(k) clearance on 2016-07-20 under 510(k) number K153328. 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 SUNCO Mechanical Wheelchair, model SKW-9003?

SUNCO Mechanical Wheelchair, model SKW-9003 is a medical device that received FDA 510(k) clearance on 2016-07-20. The listed applicant is Danyang Sunco Machinery Co., Ltd.. The 510(k) number is K153328.

When did SUNCO Mechanical Wheelchair, model SKW-9003 receive FDA 510(k) clearance?

SUNCO Mechanical Wheelchair, model SKW-9003 received FDA 510(k) clearance on 2016-07-20, under 510(k) number K153328.

Who is the listed applicant for SUNCO Mechanical Wheelchair, model SKW-9003?

The FDA 510(k) record lists Danyang Sunco Machinery Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SUNCO Mechanical Wheelchair, model SKW-9003?

The FDA product code for SUNCO Mechanical Wheelchair, model SKW-9003 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

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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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