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FDA 510(k)

MODIFICATION TO:KNEEHAB XP CONDUCTIVE GARMENT, MODEL 411

K-Number: K092793 · 2009-12-07

ApplicantBio-Medical Research, Ltd.
Decision Date2009-12-07
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO:KNEEHAB XP CONDUCTIVE GARMENT, MODEL 411 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 2009-12-07 under 510(k) number K092793. 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 MODIFICATION TO:KNEEHAB XP CONDUCTIVE GARMENT, MODEL 411?

MODIFICATION TO:KNEEHAB XP CONDUCTIVE GARMENT, MODEL 411 is a medical device that received FDA 510(k) clearance on 2009-12-07. The listed applicant is Bio-Medical Research, Ltd.. The 510(k) number is K092793.

When did MODIFICATION TO:KNEEHAB XP CONDUCTIVE GARMENT, MODEL 411 receive FDA 510(k) clearance?

MODIFICATION TO:KNEEHAB XP CONDUCTIVE GARMENT, MODEL 411 received FDA 510(k) clearance on 2009-12-07, under 510(k) number K092793.

Who is the listed applicant for MODIFICATION TO:KNEEHAB XP CONDUCTIVE GARMENT, MODEL 411?

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 MODIFICATION TO:KNEEHAB XP CONDUCTIVE GARMENT, MODEL 411?

The FDA product code for MODIFICATION TO:KNEEHAB XP CONDUCTIVE GARMENT, MODEL 411 is GXY.

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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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