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FDA 510(k)

Foot and Hand Motion

K-Number: K170012 · 2017-04-24

Decision Date2017-04-24
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Foot and Hand Motion is a medical device manufactured by Newclip Technics. It received FDA 510(k) clearance on 2017-04-24 under approval number K170012. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Foot and Hand Motion?

Foot and Hand Motion is a medical device that received FDA 510(k) clearance on 2017-04-24. It is manufactured by Newclip Technics. The 510(k) number is K170012.

When was Foot and Hand Motion approved by the FDA?

Foot and Hand Motion received FDA 510(k) clearance on 2017-04-24, under approval number K170012.

What company makes Foot and Hand Motion?

Foot and Hand Motion is manufactured by Newclip Technics.

What is the FDA product code for Foot and Hand Motion?

The FDA product code for Foot and Hand Motion is HWC. This falls under the Cardiovascular category.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.