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FDA 510(k)

Foot Drop System (Model XFT-2001D)

K-Number: K162718 · 2017-11-30

ApplicantShenzhen Xft Medical Limited
Decision Date2017-11-30
Product CodeGZI
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Foot Drop System (Model XFT-2001D) is a medical device manufactured by Shenzhen Xft Medical Limited. It received FDA 510(k) clearance on 2017-11-30 under approval number K162718. The device is classified under product code GZI. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Foot Drop System (Model XFT-2001D)?

Foot Drop System (Model XFT-2001D) is a medical device that received FDA 510(k) clearance on 2017-11-30. It is manufactured by Shenzhen Xft Medical Limited. The 510(k) number is K162718.

When was Foot Drop System (Model XFT-2001D) approved by the FDA?

Foot Drop System (Model XFT-2001D) received FDA 510(k) clearance on 2017-11-30, under approval number K162718.

What company makes Foot Drop System (Model XFT-2001D)?

Foot Drop System (Model XFT-2001D) is manufactured by Shenzhen Xft Medical Limited.

What is the FDA product code for Foot Drop System (Model XFT-2001D)?

The FDA product code for Foot Drop System (Model XFT-2001D) is GZI.

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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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