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FDA 510(k)

AST Model MA012 and MS019 Rehab Wheelchair

K-Number: K181795 · 2018-09-25

ApplicantSichuan Ast Medical Equipment Co., Ltd.
Decision Date2018-09-25
Product CodeIOR
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

AST Model MA012 and MS019 Rehab Wheelchair is a medical device manufactured by Sichuan Ast Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2018-09-25 under approval number K181795. 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 AST Model MA012 and MS019 Rehab Wheelchair?

AST Model MA012 and MS019 Rehab Wheelchair is a medical device that received FDA 510(k) clearance on 2018-09-25. It is manufactured by Sichuan Ast Medical Equipment Co., Ltd.. The 510(k) number is K181795.

When was AST Model MA012 and MS019 Rehab Wheelchair approved by the FDA?

AST Model MA012 and MS019 Rehab Wheelchair received FDA 510(k) clearance on 2018-09-25, under approval number K181795.

What company makes AST Model MA012 and MS019 Rehab Wheelchair?

AST Model MA012 and MS019 Rehab Wheelchair is manufactured by Sichuan Ast Medical Equipment Co., Ltd..

What is the FDA product code for AST Model MA012 and MS019 Rehab Wheelchair?

The FDA product code for AST Model MA012 and MS019 Rehab Wheelchair is IOR.

Related Clinical Trials

NCT03053791 Deep Brain Stimulation in Patients With Incomplete Spinal Cord Injury for Improvement of Gait RECRUITING

Other Devices by Sichuan Ast Medical Equipment Co., Ltd.

K231750MA012 Aluminum wheelchair, MS019 steel wheelchair K242722Manual Wheelchair (MASY23)

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.

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