Cleared Traditional

K022846 - SW-180 SHORTWAVE THERAPY UNIT

K022846 is an FDA 510(k) clearance for SW-180 SHORTWAVE THERAPY UNIT, manufactured by Ito Co., Ltd.. The device is a Class 2 Physical Medicine device with product code IMJ cleared through the Traditional 510(k) pathway after a 154-day FDA review.

K022846 · Ito Co., Ltd. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2003
Decision
154d
Days
Class 2
Risk

K022846 is an FDA 510(k) clearance for the SW-180 SHORTWAVE THERAPY UNIT. Classified as Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat (product code IMJ), Class II - Special Controls.

Submitted by Ito Co., Ltd. (Brookeville, US). The FDA issued a Cleared decision on January 28, 2003 after a review of 154 days - an extended review cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5290 - 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 Ito Co., Ltd. devices

FDA 510(k) Submission Details - K022846

510(k) Number K022846 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 2002
Decision Date January 28, 2003
Days to Decision 154 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
39d slower than avg
Panel avg: 115d · This submission: 154d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IMJ Device Classification - Class 2, Special Controls

Product Code IMJ Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5290
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 - IMJ Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat

All 19
Devices cleared under the same product code (IMJ) and FDA review panel - the closest regulatory comparables to K022846.
SW-THERM
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MODEL 2060 W/6 CM(2) & MODEL 2100 W/10 CM(2) TRANS
K864653 · Rich-Mar Corp. · Dec 1986
THE BIO-TEK UW-II
K862932 · Bio-Tek Instruments, Inc. · Sep 1986