Cleared Traditional

K153456 - Megapulse III Shortwave Diathermy (FDA 510(k) Clearance)

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

K153456 · Accelerated Care Plus · Physical Medicine device
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Jun 2016
Decision
196d
Days
Class 2
Risk

K153456 is an FDA 510(k) clearance for the Megapulse III Shortwave Diathermy. Classified as Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat (product code IMJ), Class II - Special Controls.

Submitted by Accelerated Care Plus (Reno, US). The FDA issued a Cleared decision on June 14, 2016 after a review of 196 days - an extended review cycle.

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.

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Submission Details

510(k) Number K153456 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 2015
Decision Date June 14, 2016
Days to Decision 196 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
81d slower than avg
Panel avg: 115d · This submission: 196d
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.