Cleared Traditional

K934845 - SONICATOR 715

K934845 is the FDA 510(k) clearance for SONICATOR 715 by Mettler Electronics Corp.. It is a Class 2 Physical Medicine device (product code IMG) cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K934845 · Mettler Electronics Corp. · Physical Medicine device
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Jan 1994
Decision
105d
Days
Class 2
Risk

K934845 is an FDA 510(k) clearance for the SONICATOR 715. 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 January 21, 1994 after a review of 105 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. 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 Mettler Electronics Corp. devices

Submission Details

510(k) Number K934845 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 08, 1993
Decision Date January 21, 1994
Days to Decision 105 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
10d faster than avg
Panel avg: 115d · This submission: 105d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 30
Devices cleared under the same product code (IMG) and FDA review panel - the closest regulatory comparables to K934845.
FORTE US
K940180 · Chattanooga Group, Inc. · Apr 1994
SONICATOR 716
K934846 · Mettler Electronics Corp. · Mar 1994
THERAPEUTIC ULTRASOUND AND STIMULATOR
K935271 · Chattanooga Group, Inc. · Feb 1994
SONOPULS 591
K922036 · Henley Intl. · Jun 1993
SONICATOR PLUS
K921436 · Mettler Electronics Corp. · Apr 1993
ULTRA III
K921952 · Excel Tech. , Ltd. · Mar 1993