Cleared Traditional

INTELECT SWD 100, MODEL 1600 (K083433) - FDA 510(k) Clearance

Also marketed or referenced as:
SENIOR SOLUTIONS SHORTWAVE DIATHERMY, MODEL 1601

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

K083433 · Chattanooga Group · Physical Medicine device
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Mar 2009
Decision
118d
Days
Class 2
Risk

K083433 is an FDA 510(k) clearance for the INTELECT SWD 100, MODEL 1600. Classified as Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat (product code IMJ), Class II - Special Controls.

Submitted by Chattanooga Group (Hixson, US). The FDA issued a Cleared decision on March 18, 2009 after a review of 118 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 Chattanooga Group devices

Submission Details

510(k) Number K083433 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 2008
Decision Date March 18, 2009
Days to Decision 118 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
3d slower than avg
Panel avg: 115d · This submission: 118d
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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