Cleared Traditional

K112520 - US-101L, US-103S

K112520 is an FDA 510(k) clearance for US-101L, 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 56-day FDA review.

K112520 · Ito Co., Ltd. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2011
Decision
56d
Days
Class 2
Risk

K112520 is an FDA 510(k) clearance for the US-101L, US-103S. Classified as Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat (product code IMI), Class II - Special Controls.

Submitted by Ito Co., Ltd. (Tokyo, JP). The FDA issued a Cleared decision on October 26, 2011 after a review of 56 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 - K112520

510(k) Number K112520 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 2011
Decision Date October 26, 2011
Days to Decision 56 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 116d · This submission: 56d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Tuv Sud America, Inc.
ALEXANDER SCHAPOVALOV

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - IMI Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat

All 71
Devices cleared under the same product code (IMI) and FDA review panel - the closest regulatory comparables to K112520.
SONOPULSE/ SONOPULSE III
K130888 · Ibramed- Industria Brazileria DE Equipamentos Medi · Jan 2014
ACCUSONIC ADVANTAGE
K124010 · Metron Medical Australia, Pty, Ltd. · Aug 2013
ACCUSONIC ADVANTAGE
K120171 · Metron Medical Australia, Pty, Ltd. · May 2012
MED CONTOUR
K091615 · General Project S.R.L. · May 2010
SUN-RAIN ULTRASONIC THERAPY MODELS, SU-300, SU-400, SU-500, SU-600, SU-700, SU-800, SU-900
K090542 · Sun-Rain System Corp. · Oct 2009
HF54 COMBINATION ULTRASOUND INTERFERENTIAL AND PREMODULATED STIMULATION SYSTEM
K062256 · Hill Laboratories Co. · Feb 2007

FDA 510(k) Resources - Physical Medicine

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.