Cleared Traditional

K934287 - DYNASOUND MODEL 401 THERAPEUTIC ULTRASO...

K934287 is the FDA 510(k) clearance for DYNASOUND MODEL 401 THERAPEUTIC ULTRASO... by Dynawave, Corp.. It is a Class 2 Physical Medicine device (product code IMG) cleared through the Traditional 510(k) pathway after a 214-day FDA review.

K934287 · Dynawave, Corp. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1994
Decision
214d
Days
Class 2
Risk

K934287 is an FDA 510(k) clearance for the DYNASOUND MODEL 401 THERAPEUTIC ULTRASOUND STIMULATOR. Classified as Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat (product code IMG), Class II - Special Controls.

Submitted by Dynawave, Corp. (Geneva, US). The FDA issued a Cleared decision on April 4, 1994 after a review of 214 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 Dynawave, Corp. devices

Submission Details

510(k) Number K934287 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 02, 1993
Decision Date April 04, 1994
Days to Decision 214 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
99d slower than avg
Panel avg: 115d · This submission: 214d
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 31
Devices cleared under the same product code (IMG) and FDA review panel - the closest regulatory comparables to K934287.
SONICATOR 730
K943469 · Mettler Electronics Corp. · Aug 1994
FORTE US
K941561 · Chattanooga Group, Inc. · Jun 1994
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
SONICATOR 715
K934845 · Mettler Electronics Corp. · Jan 1994