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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 a medical device manufactured by Danyang Sunco Machinery Co., Ltd.. It received FDA 510(k) clearance on 2016-07-20 under approval 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. It is manufactured by Danyang Sunco Machinery Co., Ltd.. The 510(k) number is K153328.

When was SUNCO Mechanical Wheelchair, model SKW-9003 approved by the FDA?

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

What company makes SUNCO Mechanical Wheelchair, model SKW-9003?

SUNCO Mechanical Wheelchair, model SKW-9003 is manufactured by Danyang Sunco Machinery Co., Ltd..

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.

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Related PubMed Literature

PMID: 41804390 Modeling In-Hospital Mortality Among Patients Undergoing Percutaneous Coronary Intervention with Acute Myocardial Infarction Complicated by Cardiogenic Shock Receiving Mechanical Circulatory Support. Medical devices (Auckland, N.Z.) (2026) PMID: 41358283 Modeling In-Hospital Mortality Among Patients Undergoing Percutaneous Coronary Intervention with Acute Myocardial Infarction Complicated by Cardiogenic Shock Receiving Mechanical Circulatory Support. medRxiv : the preprint server for health sciences (2025) PMID: 40868376 Correlation Analysis of Suture Anchor Pull-Out Strength with Cortical Bone Thickness and Cancellous Bone Density on a Finite Element Model. Bioengineering (Basel, Switzerland) (2025)

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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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