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)

Manual Wheelchair SIVFH2A102

K-Number: K190534 · 2019-05-29

ApplicantJiangsu Horizon Medical Science & Technology Co., Ltd.
Decision Date2019-05-29
Product CodeIOR
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Manual Wheelchair SIVFH2A102 is a medical device manufactured by Jiangsu Horizon Medical Science & Technology Co., Ltd.. It received FDA 510(k) clearance on 2019-05-29 under approval number K190534. 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 Manual Wheelchair SIVFH2A102?

Manual Wheelchair SIVFH2A102 is a medical device that received FDA 510(k) clearance on 2019-05-29. It is manufactured by Jiangsu Horizon Medical Science & Technology Co., Ltd.. The 510(k) number is K190534.

When was Manual Wheelchair SIVFH2A102 approved by the FDA?

Manual Wheelchair SIVFH2A102 received FDA 510(k) clearance on 2019-05-29, under approval number K190534.

What company makes Manual Wheelchair SIVFH2A102?

Manual Wheelchair SIVFH2A102 is manufactured by Jiangsu Horizon Medical Science & Technology Co., Ltd..

What is the FDA product code for Manual Wheelchair SIVFH2A102?

The FDA product code for Manual Wheelchair SIVFH2A102 is IOR.

Related Clinical Trials

NCT05776030 Multi-speed Ergonomic Wheelchair RECRUITING NCT04668326 Mobile Manual Standing Wheelchair for SCI COMPLETED

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.

↑