Cleared Traditional

K895690 - ULTRA (THERAPEUTIC ULTRASOUND DEVICE)

K895690 is the FDA 510(k) clearance for ULTRA (THERAPEUTIC ULTRASOUND DEVICE) by Excel Tech. , Ltd.. It is a Class 2 Physical Medicine device (product code IMG) cleared through the Traditional 510(k) pathway after a 151-day FDA review.

K895690 · Excel Tech. , Ltd. · Physical Medicine device
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Feb 1990
Decision
151d
Days
Class 2
Risk

K895690 is an FDA 510(k) clearance for the ULTRA (THERAPEUTIC ULTRASOUND DEVICE). Classified as Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat (product code IMG), Class II - Special Controls.

Submitted by Excel Tech. , Ltd. (Oakville,Ontario, CA). The FDA issued a Cleared decision on February 20, 1990 after a review of 151 days - an extended review cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5860 - 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 K895690 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 1989
Decision Date February 20, 1990
Days to Decision 151 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
36d slower than avg
Panel avg: 115d · This submission: 151d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IMG Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5860
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 - IMG Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat

All 24
Devices cleared under the same product code (IMG) and FDA review panel - the closest regulatory comparables to K895690.
INTELECT 170
K902860 · Chattanooga Group, Inc. · Sep 1990
INTELECT 750 MP
K902875 · Chattanooga Group, Inc. · Sep 1990
CURAPULS 403 DIATHERMY UNIT
K900189 · Henley Intl. · Sep 1990
SONOPULS 464, ULTRASOUND THERAPY EQUIPMENT
K872394 · Henley Intl. · Sep 1987
RICH-MAR DELTA 330 HV
K844217 · Rich-Mar Corp. · Nov 1984
INTELECT MODEL 700
K813594 · Chattanooga Group, Inc. · Feb 1982