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FDA 510(k)

XINIWAVE, MODEL XW-18

K-Number: K100441 · 2010-07-15

ApplicantInternational Trade Group, Inc.
Decision Date2010-07-15
Product CodeNUH
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

XINIWAVE, MODEL XW-18 is the device name listed in this FDA 510(k) record. The listed applicant is International Trade Group, Inc.. It received FDA 510(k) clearance on 2010-07-15 under 510(k) number K100441. The device is classified under product code NUH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the XINIWAVE, MODEL XW-18?

XINIWAVE, MODEL XW-18 is a medical device that received FDA 510(k) clearance on 2010-07-15. The listed applicant is International Trade Group, Inc.. The 510(k) number is K100441.

When did XINIWAVE, MODEL XW-18 receive FDA 510(k) clearance?

XINIWAVE, MODEL XW-18 received FDA 510(k) clearance on 2010-07-15, under 510(k) number K100441.

Who is the listed applicant for XINIWAVE, MODEL XW-18?

The FDA 510(k) record lists International Trade Group, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for XINIWAVE, MODEL XW-18?

The FDA product code for XINIWAVE, MODEL XW-18 is NUH.

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Other records listing International Trade Group, Inc. as applicant

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Related Devices (Code: NUH)

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

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