Cleared Traditional

K063728 - TNN-DU810 NON-INVASIVE SUBDERMAL THERAPY SYSTEM

K063728 is an FDA 510(k) clearance for TNN-DU810 NON-INVASIVE SUBDERMAL THERAP..., 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 110-day FDA review.

K063728 · Alfa Tech Medical Systems, Ltd. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2007
Decision
110d
Days
Class 2
Risk

K063728 is an FDA 510(k) clearance for the TNN-DU810 NON-INVASIVE SUBDERMAL THERAPY 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 April 4, 2007 after a review of 110 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 Alfa Tech Medical Systems, Ltd. devices

FDA 510(k) Submission Details - K063728

510(k) Number K063728 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 2006
Decision Date April 04, 2007
Days to Decision 110 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
5d faster than avg
Panel avg: 115d · This submission: 110d
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 39
Devices cleared under the same product code (IMG) and FDA review panel - the closest regulatory comparables to K063728.
SONICATOR PLUS 920
K111482 · Mettler Electronics Corp. · Aug 2011
CT2011 SONICSTIMU PAIN RELIEF DEVICE
K092627 · Shenzhen Dongdixin Technology Co., Ltd. · Jan 2010
SONICATOR PLUS 940, MODEL ME940
K071137 · Mettler Electronics Corp. · Aug 2007
VECTORSONIC, MODEL VU-270
K030880 · Metron Medical Australia, Pty, Ltd. · Apr 2003
RELIANT BTL 5000 PULS ELECTRICAL STIMULATION SYSTEM, RELIANT BTL 5000 SONO ULTRASOUND SYSTEM, RELIANT BTL 5000 COMBI
K023050 · Reliant Technologies, Inc. · Feb 2003
VECTORSONIC, MODEL VU-200
K020119 · Metron Medical Australia, Pty, Ltd. · Jul 2002