Cleared Traditional

K032793 - US-100 PORTABLE ULTRASOUND THERAPY UNIT

K032793 is an FDA 510(k) clearance for US-100 PORTABLE ULTRASOUND THERAPY UNIT, manufactured by Ito Co., Ltd.. The device is a Class 2 Physical Medicine device with product code IMI cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K032793 · Ito Co., Ltd. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2003
Decision
30d
Days
Class 2
Risk

K032793 is an FDA 510(k) clearance for the US-100 PORTABLE ULTRASOUND THERAPY UNIT. Classified as Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat (product code IMI), Class II - Special Controls.

Submitted by Ito Co., Ltd. (Brookeville, US). The FDA issued a Cleared decision on October 9, 2003 after a review of 30 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Ito Co., Ltd. devices

FDA 510(k) Submission Details - K032793

510(k) Number K032793 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 2003
Decision Date October 09, 2003
Days to Decision 30 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
85d faster than avg
Panel avg: 115d · This submission: 30d
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 36
Devices cleared under the same product code (IMI) and FDA review panel - the closest regulatory comparables to K032793.
UltraTENS
K142976 · Shenzhen Dongdixin Technology Co., Ltd. · Aug 2015
SONICATOR 740, MODEL ME 740
K053546 · Mettler Electronics Corp. · May 2006
DYNATRON SOLARIS SERIES, MODELS 705, 706, 708, 709 D880 INFRARED PROBE (OPTIONAL ACCESSORY)
K031329 · Dynatronics Corp. · Oct 2003
RICH-MAR THERASOUND 6.5 THERAPEUTIC ULTRASOUND
K021483 · Rich-Mar Corp. · Sep 2002
SONICATOR PLUS 930, MODEL ME 930
K013192 · Mettler Electronics Corp. · Oct 2001
RICH-MAR US500, US750, US1000 THERAPEUTIC UNLTRASOUND DEVICES
K982544 · Rich-Mar Corp. · Nov 1998