FDA 510(k)

AVIVAFIX CONDUCTIVE GARMENT-KNEE/SHOULDER/UPPER BACK, TYPE 40

K-Number: K102614 · 2011-06-03

Decision Date2011-06-03

Product CodeGXY

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

AVIVAFIX CONDUCTIVE GARMENT-KNEE/SHOULDER/UPPER BACK, TYPE 40 is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Medical Research, Ltd.. It received FDA 510(k) clearance on 2011-06-03 under 510(k) number K102614. The device is classified under product code GXY. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AVIVAFIX CONDUCTIVE GARMENT-KNEE/SHOULDER/UPPER BACK, TYPE 40?

AVIVAFIX CONDUCTIVE GARMENT-KNEE/SHOULDER/UPPER BACK, TYPE 40 is a medical device that received FDA 510(k) clearance on 2011-06-03. The listed applicant is Bio-Medical Research, Ltd.. The 510(k) number is K102614.

When did AVIVAFIX CONDUCTIVE GARMENT-KNEE/SHOULDER/UPPER BACK, TYPE 40 receive FDA 510(k) clearance?

AVIVAFIX CONDUCTIVE GARMENT-KNEE/SHOULDER/UPPER BACK, TYPE 40 received FDA 510(k) clearance on 2011-06-03, under 510(k) number K102614.

Who is the listed applicant for AVIVAFIX CONDUCTIVE GARMENT-KNEE/SHOULDER/UPPER BACK, TYPE 40?

The FDA 510(k) record lists Bio-Medical Research, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AVIVAFIX CONDUCTIVE GARMENT-KNEE/SHOULDER/UPPER BACK, TYPE 40?

The FDA product code for AVIVAFIX CONDUCTIVE GARMENT-KNEE/SHOULDER/UPPER BACK, TYPE 40 is GXY.

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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.