Cleared Traditional

K930186 - INTERTRON 6000/6100

K930186 is an FDA 510(k) clearance for INTERTRON 6000/6100, manufactured by Williams Healthcare Systems, LLC. The device is a Class 2 Physical Medicine device with product code IMI cleared through the Traditional 510(k) pathway after a 169-day FDA review.

K930186 · Williams Healthcare Systems, LLC · Physical Medicine device
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Jul 1993
Decision
169d
Days
Class 2
Risk

K930186 is an FDA 510(k) clearance for the INTERTRON 6000/6100. Classified as Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat (product code IMI), Class II - Special Controls.

Submitted by Williams Healthcare Systems, LLC (Lenexa, US). The FDA issued a Cleared decision on July 2, 1993 after a review of 169 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 Williams Healthcare Systems, LLC devices

FDA 510(k) Submission Details - K930186

510(k) Number K930186 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 14, 1993
Decision Date July 02, 1993
Days to Decision 169 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
54d slower than avg
Panel avg: 115d · This submission: 169d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IMI Device Classification - Class 2, Special Controls

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 36
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