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

FDA 510(k)

SUNTEC Mechanical Wheelchair, model ST-WL-1000

K-Number: K152878 · 2016-02-03

ApplicantDanyang Suntec Auto Parts Co., Ltd.
Decision Date2016-02-03
Product CodeIOR
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

SUNTEC Mechanical Wheelchair, model ST-WL-1000 is a medical device manufactured by Danyang Suntec Auto Parts Co., Ltd.. It received FDA 510(k) clearance on 2016-02-03 under approval number K152878. 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 SUNTEC Mechanical Wheelchair, model ST-WL-1000?

SUNTEC Mechanical Wheelchair, model ST-WL-1000 is a medical device that received FDA 510(k) clearance on 2016-02-03. It is manufactured by Danyang Suntec Auto Parts Co., Ltd.. The 510(k) number is K152878.

When was SUNTEC Mechanical Wheelchair, model ST-WL-1000 approved by the FDA?

SUNTEC Mechanical Wheelchair, model ST-WL-1000 received FDA 510(k) clearance on 2016-02-03, under approval number K152878.

What company makes SUNTEC Mechanical Wheelchair, model ST-WL-1000?

SUNTEC Mechanical Wheelchair, model ST-WL-1000 is manufactured by Danyang Suntec Auto Parts Co., Ltd..

What is the FDA product code for SUNTEC Mechanical Wheelchair, model ST-WL-1000?

The FDA product code for SUNTEC Mechanical Wheelchair, model ST-WL-1000 is IOR.

Related Clinical Trials

NCT03053791 Deep Brain Stimulation in Patients With Incomplete Spinal Cord Injury for Improvement of Gait RECRUITING NCT07557238 CHIP-CC Registry: A Prospective Multicenter Registry of Complex High-Risk PCI in China NOT_YET_RECRUITING NCT07367620 Immediate Mechanical Complications After Central Venous Catheterization COMPLETED NCT05173870 Remote Monitoring to Prevent Frailty Progression in the Elderly TERMINATED

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)

Related Devices (Code: IOR)

K162696Kuschall Advance Manual WheelchairInvacare Corporation K162686Kuschall Champion Manual WheelchairInvacare Corporation K162692Kuschall K-Series Attract Manual WheelchairInvacare Corporation K161425APEX Manual WheelchairMotion Composites K153328SUNCO Mechanical Wheelchair, model SKW-9003Danyang Sunco Machinery Co., Ltd. K151492KuduR82 A/S

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.

↑