Cleared Traditional

K112890 - NORMATEC MVP

K112890 is an FDA 510(k) clearance for NORMATEC MVP, manufactured by NormaTec Industries, LP. The device is a Class 2 Physical Medicine device with product code IRP cleared through the Traditional 510(k) pathway after a 96-day FDA review.

K112890 · NormaTec Industries, LP · Physical Medicine device
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Jan 2012
Decision
96d
Days
Class 2
Risk

K112890 is an FDA 510(k) clearance for the NORMATEC MVP. Classified as Massager, Powered Inflatable Tube (product code IRP), Class II - Special Controls.

Submitted by NormaTec Industries, LP (Washington, US). The FDA issued a Cleared decision on January 4, 2012 after a review of 96 days - within the typical 510(k) review window.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5650 - the FDA physical medicine device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all NormaTec Industries, LP devices

FDA 510(k) Submission Details - K112890

510(k) Number K112890 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2011
Decision Date January 04, 2012
Days to Decision 96 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
19d faster than avg
Panel avg: 115d · This submission: 96d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IRP Device Classification - Class 2, Special Controls

Product Code IRP Massager, Powered Inflatable Tube
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5650
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 - IRP Massager, Powered Inflatable Tube

All 99
Devices cleared under the same product code (IRP) and FDA review panel - the closest regulatory comparables to K112890.
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EBI FOOT MASSAGING PUMP
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INTERMITTENT COMPRESSION PUMPS
K832920 · Chattanooga Group, Inc. · Nov 1983