Cleared Traditional

K052340 - DU857 DUAL FREQUENCY ULTRASOUND THERAPY AND MUSCLE STIMULATOR SYSTEM

K052340 is an FDA 510(k) clearance for DU857 DUAL FREQUENCY ULTRASOUND THERAPY..., manufactured by Alfa Tech Medical Systems, Ltd.. The device is a Class 2 Physical Medicine device with product code IMG cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K052340 · Alfa Tech Medical Systems, Ltd. · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2005
Decision
105d
Days
Class 2
Risk

K052340 is an FDA 510(k) clearance for the DU857 DUAL FREQUENCY ULTRASOUND THERAPY AND MUSCLE STIMULATOR SYSTEM. Classified as Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat (product code IMG), Class II - Special Controls.

Submitted by Alfa Tech Medical Systems, Ltd. (Great Neck, US). The FDA issued a Cleared decision on December 9, 2005 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.

FDA 510(k) Submission Details - K052340

510(k) Number K052340 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 2005
Decision Date December 09, 2005
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
11d faster than avg
Panel avg: 116d · This submission: 105d
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 53
Devices cleared under the same product code (IMG) and FDA review panel - the closest regulatory comparables to K052340.
SONICATOR PLUS 940, MODEL ME940
K071137 · Mettler Electronics Corp. · Aug 2007
TNN-DU810 NON-INVASIVE SUBDERMAL THERAPY SYSTEM
K063728 · Alfa Tech Medical Systems, Ltd. · Apr 2007
SONIC-STIM
K063135 · Naimco, Inc. · Feb 2007
VECTRA TRANSPORTABLE COMBO AND STIM (SPECIALTY LINE DEALERS)
K040285 · Chattanooga Group · Apr 2004
DERMAWAVE 5000 COMBI MAX SYSTEM
K040121 · Dermawave, LLC · Mar 2004
VECTRA EPR SYSTEM AND INTELECT EPR SYSTEM
K031077 · Chattanooga Group · Dec 2003
K052340 · DU857 DUAL FREQUENCY ULTRASOUND THERAPY AND MUSCLE STIMULATOR SYSTEM
Download PDF FDA Summary Alfa Tech Medical Sys…