Cleared Traditional

SOUNDTEK MODEL UT-4700 (K864766) - FDA 510(k) Clearance

Class II Physical Medicine device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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.

Device Classification

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 43
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