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
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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
20d faster than avg
Panel avg: 116d · 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 138
Devices cleared under the same product code (IRP) and FDA review panel - the closest regulatory comparables to K112890.
COMPRESSIBLE LIMB AND CIRCULATION THERAPY SYSTEM
K120166 · Won Industrial Co. · May 2012
COMPRESSIBLE LIMB THERAPY SYSTEM
K113275 · Wonjin Mulsan Co., Ltd. · Feb 2012
COMPRESSIBLE LIMB AND CIRCULATION THERAPY SYSTEM
K112441 · Daesung Maref Co., Ltd. · Jan 2012
DSJ MASSAGER
K112479 · Mego Afek AC , Ltd. · Dec 2011
COMPRESSIBLE LIMB AND CIRCULATION THERAPY SYSTEM MODEL LX7(V7)
K102320 · Daesung Maref Co., Ltd. · Mar 2011
COMPRESSIBLE LIMB AND CIRCULATION THERAPY SYSTEM MODEL WIC-2008
K102319 · Won Industrial Co. · Jan 2011