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FDA 510(k)

LUMBOFIX CONDUCTIVE GARMENT, MODEL 420 BACK

K-Number: K091317 · 2009-06-25

ApplicantBio-Medical Research, Ltd.
Decision Date2009-06-25
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

LUMBOFIX CONDUCTIVE GARMENT, MODEL 420 BACK 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 2009-06-25 under 510(k) number K091317. The device is classified under product code GZJ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LUMBOFIX CONDUCTIVE GARMENT, MODEL 420 BACK?

LUMBOFIX CONDUCTIVE GARMENT, MODEL 420 BACK is a medical device that received FDA 510(k) clearance on 2009-06-25. The listed applicant is Bio-Medical Research, Ltd.. The 510(k) number is K091317.

When did LUMBOFIX CONDUCTIVE GARMENT, MODEL 420 BACK receive FDA 510(k) clearance?

LUMBOFIX CONDUCTIVE GARMENT, MODEL 420 BACK received FDA 510(k) clearance on 2009-06-25, under 510(k) number K091317.

Who is the listed applicant for LUMBOFIX CONDUCTIVE GARMENT, MODEL 420 BACK?

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 LUMBOFIX CONDUCTIVE GARMENT, MODEL 420 BACK?

The FDA product code for LUMBOFIX CONDUCTIVE GARMENT, MODEL 420 BACK is GZJ.

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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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