Cleared Traditional

K050410 - HES ULTRASONIC THERAPY APPLIANCE, MODELS HS-3008 (1MHZ), HS3026 (2MHZ), HS-3040 (3MHZ)

K050410 is an FDA 510(k) clearance for HES ULTRASONIC THERAPY APPLIANCE, manufactured by Hwang Sun Enterprise Co., Ltd.. The device is a Class 2 Physical Medicine device with product code IMI cleared through the Traditional 510(k) pathway after a 147-day FDA review.

K050410 · Hwang Sun Enterprise Co., Ltd. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2005
Decision
147d
Days
Class 2
Risk

K050410 is an FDA 510(k) clearance for the HES ULTRASONIC THERAPY APPLIANCE, MODELS HS-3008 (1MHZ), HS3026 (2MHZ), HS-30.... Classified as Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat (product code IMI), Class II - Special Controls.

Submitted by Hwang Sun Enterprise Co., Ltd. (Middle Island, US). The FDA issued a Cleared decision on July 14, 2005 after a review of 147 days - within the typical 510(k) review window.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5300 - 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 - K050410

510(k) Number K050410 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 17, 2005
Decision Date July 14, 2005
Days to Decision 147 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
31d slower than avg
Panel avg: 116d · This submission: 147d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IMI Device Classification - Class 2, Special Controls

Product Code IMI Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5300
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 - IMI Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat

All 86
Devices cleared under the same product code (IMI) and FDA review panel - the closest regulatory comparables to K050410.
MED SCULPT
K053041 · General Project S.R.L. · Aug 2006
DERMOSONIC NON-INVASIVE SUBDERMAL THERAPY SYSTEM
K052934 · S.O.R. Internacional, S.A. · Jun 2006
SONICATOR 740, MODEL ME 740
K053546 · Mettler Electronics Corp. · May 2006
HES ULTRASONIC THERAPY APPLIANCE
K040798 · Hwang Sun Enterprise Co., Ltd. · Aug 2004
VECTRA (INTELECT) EPR ULTRASOUND
K031116 · Chattanooga Group · Dec 2003
SUN-RAIN ULTRASONIC THERAPY, SU-100
K024013 · Sun-Rain System Corp. · Oct 2003
K050410 · HES ULTRASONIC THERAPY APPLIANCE, MODELS HS-3008 (1MHZ), HS3026 (2MHZ), HS-3040 (3MHZ)
Download PDF Hwang Sun Enterprise …