Cleared Traditional

K864766 - SOUNDTEK MODEL UT-4700

K864766 is an FDA 510(k) clearance for SOUNDTEK MODEL UT-4700, manufactured by Soundtek, Inc.. The device is a Class 2 Physical Medicine device with product code IMJ cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K864766 · Soundtek, Inc. · Physical Medicine device
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Mar 1987
Decision
97d
Days
Class 2
Risk

K864766 is an FDA 510(k) clearance for the SOUNDTEK MODEL UT-4700. Classified as Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat (product code IMJ), Class II - Special Controls.

Submitted by Soundtek, Inc. (Geneva, US). The FDA issued a Cleared decision on March 12, 1987 after a review of 97 days - within the typical 510(k) review window.

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 Soundtek, Inc. devices

FDA 510(k) Submission Details - K864766

510(k) Number K864766 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 1986
Decision Date March 12, 1987
Days to Decision 97 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
18d faster than avg
Panel avg: 115d · This submission: 97d
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 30
Devices cleared under the same product code (IMJ) and FDA review panel - the closest regulatory comparables to K864766.
ULTRATHERM (908)
K964083 · Sie-Med, Inc. · Apr 1997
VASOTHERM
K962243 · Ehti Medical Corp. · Feb 1997
THEE THERMASTIM
K962703 · Ehti Medical Corp. · Feb 1997
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
ULTRATHERM 808 I
K862589 · Elmed, Inc. · Aug 1986