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 the device name listed in this FDA 510(k) record. The listed applicant is Newclip Technics. It received FDA 510(k) clearance on 2017-04-24 under 510(k) 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. The listed applicant is Newclip Technics. The 510(k) number is K170012.

When did Foot and Hand Motion receive FDA 510(k) clearance?

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

Who is the listed applicant for Foot and Hand Motion?

The FDA 510(k) record lists Newclip Technics as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Newclip Technics 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.

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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.