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FDA 510(k)

Dexus Prosthetics System (Model: MSL1, MSR1)

K-Number: K220002 · 2022-09-09

ApplicantZhejiang Qiangnao Technology Co.,Ltd
Decision Date2022-09-09
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Dexus Prosthetics System (Model: MSL1, MSR1) is a medical device manufactured by Zhejiang Qiangnao Technology Co.,Ltd. It received FDA 510(k) clearance on 2022-09-09 under approval number K220002. The device is classified under product code GXY. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Dexus Prosthetics System (Model: MSL1, MSR1)?

Dexus Prosthetics System (Model: MSL1, MSR1) is a medical device that received FDA 510(k) clearance on 2022-09-09. It is manufactured by Zhejiang Qiangnao Technology Co.,Ltd. The 510(k) number is K220002.

When was Dexus Prosthetics System (Model: MSL1, MSR1) approved by the FDA?

Dexus Prosthetics System (Model: MSL1, MSR1) received FDA 510(k) clearance on 2022-09-09, under approval number K220002.

What company makes Dexus Prosthetics System (Model: MSL1, MSR1)?

Dexus Prosthetics System (Model: MSL1, MSR1) is manufactured by Zhejiang Qiangnao Technology Co.,Ltd.

What is the FDA product code for Dexus Prosthetics System (Model: MSL1, MSR1)?

The FDA product code for Dexus Prosthetics System (Model: MSL1, MSR1) is GXY.

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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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