Cleared Special

KNEEHAB XP CONTROLLER, MODEL 411 (K092791) - FDA 510(k) Clearance

Class II Physical Medicine device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K092791 · Bio-Medical Research, Ltd. · Physical Medicine device
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Dec 2009
Decision
110d
Days
Class 2
Risk

K092791 is an FDA 510(k) clearance for the KNEEHAB XP CONTROLLER, MODEL 411. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Bio-Medical Research, Ltd. (Galway, IE). The FDA issued a Cleared decision on December 30, 2009 after a review of 110 days - within the typical 510(k) review window.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5850 - the FDA physical medicine device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Bio-Medical Research, Ltd. devices

Submission Details

510(k) Number K092791 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 2009
Decision Date December 30, 2009
Days to Decision 110 days
Submission Type Special
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
5d faster than avg
Panel avg: 115d · This submission: 110d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code IPF Stimulator, Muscle, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5850
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Physical Medicine devices follow this clearance model.

Regulatory Peers - IPF Stimulator, Muscle, Powered

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