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FDA 510(k)

MA012 Aluminum wheelchair, MS019 steel wheelchair

K-Number: K231750 · 2023-08-15

Decision Date2023-08-15
Product CodeIOR
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

MA012 Aluminum wheelchair, MS019 steel wheelchair is the device name listed in this FDA 510(k) record. The listed applicant is Sichuan Ast Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2023-08-15 under 510(k) number K231750. 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 MA012 Aluminum wheelchair, MS019 steel wheelchair?

MA012 Aluminum wheelchair, MS019 steel wheelchair is a medical device that received FDA 510(k) clearance on 2023-08-15. The listed applicant is Sichuan Ast Medical Equipment Co., Ltd.. The 510(k) number is K231750.

When did MA012 Aluminum wheelchair, MS019 steel wheelchair receive FDA 510(k) clearance?

MA012 Aluminum wheelchair, MS019 steel wheelchair received FDA 510(k) clearance on 2023-08-15, under 510(k) number K231750.

Who is the listed applicant for MA012 Aluminum wheelchair, MS019 steel wheelchair?

The FDA 510(k) record lists Sichuan Ast Medical Equipment Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MA012 Aluminum wheelchair, MS019 steel wheelchair?

The FDA product code for MA012 Aluminum wheelchair, MS019 steel wheelchair is IOR.

Other records listing Sichuan Ast Medical Equipment Co., Ltd. as applicant

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.

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.

Official Source

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