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FDA 510(k)

KNEEHAB XP CONTROLLER, MODEL 411

K-Number: K092791 · 2009-12-30

ApplicantBio-Medical Research, Ltd.
Decision Date2009-12-30
Product CodeIPF
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

KNEEHAB XP CONTROLLER, 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 2009-12-30 under 510(k) number K092791. The device is classified under product code IPF. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KNEEHAB XP CONTROLLER, MODEL 411?

KNEEHAB XP CONTROLLER, MODEL 411 is a medical device that received FDA 510(k) clearance on 2009-12-30. The listed applicant is Bio-Medical Research, Ltd.. The 510(k) number is K092791.

When did KNEEHAB XP CONTROLLER, MODEL 411 receive FDA 510(k) clearance?

KNEEHAB XP CONTROLLER, MODEL 411 received FDA 510(k) clearance on 2009-12-30, under 510(k) number K092791.

Who is the listed applicant for KNEEHAB XP CONTROLLER, 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 KNEEHAB XP CONTROLLER, MODEL 411?

The FDA product code for KNEEHAB XP CONTROLLER, MODEL 411 is IPF.

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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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