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FDA 510(k)

FOOT AND HAND MOTION SYSTEM

K-Number: K091118 · 2009-12-16

ApplicantNewclip Technics
Decision Date2009-12-16
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

FOOT AND HAND MOTION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Newclip Technics. It received FDA 510(k) clearance on 2009-12-16 under 510(k) number K091118. 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 SYSTEM?

FOOT AND HAND MOTION SYSTEM is a medical device that received FDA 510(k) clearance on 2009-12-16. The listed applicant is Newclip Technics. The 510(k) number is K091118.

When did FOOT AND HAND MOTION SYSTEM receive FDA 510(k) clearance?

FOOT AND HAND MOTION SYSTEM received FDA 510(k) clearance on 2009-12-16, under 510(k) number K091118.

Who is the listed applicant for FOOT AND HAND MOTION SYSTEM?

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 SYSTEM?

The FDA product code for FOOT AND HAND MOTION SYSTEM is HWC. This falls under the Cardiovascular category.

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Other records listing Newclip Technics as applicant

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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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