Cleared Traditional

K934846 - SONICATOR 716

K934846 is an FDA 510(k) clearance for SONICATOR 716, 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 166-day FDA review.

K934846 · Mettler Electronics Corp. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1994
Decision
166d
Days
Class 2
Risk

K934846 is an FDA 510(k) clearance for the SONICATOR 716. 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 March 23, 1994 after a review of 166 days - an extended review cycle.

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

FDA 510(k) Submission Details - K934846

510(k) Number K934846 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 08, 1993
Decision Date March 23, 1994
Days to Decision 166 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
51d slower than avg
Panel avg: 115d · This submission: 166d
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 K934846.
FORTE US
K941561 · Chattanooga Group, Inc. · Jun 1994
DYNATRON 150
K935728 · Dynatronics Corp. · Apr 1994
FORTE US
K940180 · Chattanooga Group, Inc. · Apr 1994
THERAPEUTIC ULTRASOUND AND STIMULATOR
K935271 · Chattanooga Group, Inc. · Feb 1994
SONICATOR 715
K934845 · Mettler Electronics Corp. · Jan 1994
DYNATRON 800
K932937 · Dynatronics Corp. · Oct 1993