Cleared Traditional

K923076 - ULTRA SX

K923076 is the FDA 510(k) clearance for ULTRA SX by Excel Tech. , Ltd.. It is a Class 2 Physical Medicine device (product code IMI) cleared through the Traditional 510(k) pathway after a 257-day FDA review.

K923076 · Excel Tech. , Ltd. · Physical Medicine device
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Mar 1993
Decision
257d
Days
Class 2
Risk

K923076 is an FDA 510(k) clearance for the ULTRA SX. Classified as Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat (product code IMI), Class II - Special Controls.

Submitted by Excel Tech. , Ltd. (Oakville,Ontario, CA). The FDA issued a Cleared decision on March 9, 1993 after a review of 257 days - an extended review 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: 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 Excel Tech. , Ltd. devices

Submission Details

510(k) Number K923076 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 25, 1992
Decision Date March 09, 1993
Days to Decision 257 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
142d slower than avg
Panel avg: 115d · This submission: 257d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 24
Devices cleared under the same product code (IMI) and FDA review panel - the closest regulatory comparables to K923076.
RICH-MAR US-II ULTRASOUND
K950564 · Rich-Mar Corp. · May 1995
INTELECT 222 P
K930307 · Chattanooga Group, Inc. · Jul 1993
SONOPULS 590
K920983 · Henley Intl. · Mar 1993
RICH-MAR MODEL 510 ULTRASOUND
K915557 · Rich-Mar Corp. · Mar 1992
RICH-MAR MODEL II ULTRASOUND
K913981 · Rich-Mar Corp. · Nov 1991
RICH-MAR MODEL 25 ULTRASOUND
K912202 · Rich-Mar Corp. · Sep 1991