Cleared Special

K111482 - SONICATOR PLUS 920

K111482 is an FDA 510(k) clearance for SONICATOR PLUS 920, manufactured by Mettler Electronics Corp.. The device is a Class 2 Physical Medicine device with product code IMG cleared through the Special 510(k) pathway after a 90-day FDA review.

K111482 · Mettler Electronics Corp. · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2011
Decision
90d
Days
Class 2
Risk

K111482 is an FDA 510(k) clearance for the SONICATOR PLUS 920. Classified as Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat (product code IMG), Class II - Special Controls.

Submitted by Mettler Electronics Corp. (Anaheim, US). The FDA issued a Cleared decision on August 25, 2011 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5860 - 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.

FDA 510(k) Submission Details - K111482

510(k) Number K111482 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 27, 2011
Decision Date August 25, 2011
Days to Decision 90 days
Submission Type Special
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
26d faster than avg
Panel avg: 116d · This submission: 90d
Pathway characteristics
Modification to existing cleared device.

IMG Device Classification - Class 2, Special Controls

Product Code IMG Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5860
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 - IMG Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat

All 54
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K111482 · SONICATOR PLUS 920
Download PDF FDA Summary Mettler Electronics C…