Cleared Traditional

K921436 - SONICATOR PLUS

K921436 is an FDA 510(k) clearance for SONICATOR PLUS, manufactured by Mettler Electronics Corp.. The device is a Class 2 Physical Medicine device with product code IMG cleared through the Traditional 510(k) pathway after a 398-day FDA review.

K921436 · Mettler Electronics Corp. · Physical Medicine device
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Apr 1993
Decision
398d
Days
Class 2
Risk

K921436 is an FDA 510(k) clearance for the SONICATOR PLUS. 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 April 27, 1993 after a review of 398 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5860 - 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. Elevated predicate reliance profile. 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 Mettler Electronics Corp. devices

FDA 510(k) Submission Details - K921436

510(k) Number K921436 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 25, 1992
Decision Date April 27, 1993
Days to Decision 398 days
Submission Type Traditional
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
283d slower than avg
Panel avg: 115d · This submission: 398d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 43
Devices cleared under the same product code (IMG) and FDA review panel - the closest regulatory comparables to K921436.
SONICATOR 715
K934845 · Mettler Electronics Corp. · Jan 1994
DYNATRON 800
K932937 · Dynatronics Corp. · Oct 1993
SONOPULS 591
K922036 · Henley Intl. · Jun 1993
ULTRA III
K921952 · Excel Tech. , Ltd. · Mar 1993
MODEL 25 THERAPEUTIC ULTRASOUND -- MODIFIED
K923797 · Rich-Mar Corp. · Nov 1992
INTELECT, MODEL 245
K911733 · Chattanooga Group, Inc. · Dec 1991