Cleared Traditional

K131926 - THERMOPULSE (FDA 510(k) Clearance)

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

K131926 · Ibramed Equipamentos Medicos · Physical Medicine device
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Jul 2014
Decision
393d
Days
Class 2
Risk

K131926 is an FDA 510(k) clearance for the THERMOPULSE. Classified as Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat (product code IMJ), Class II - Special Controls.

Submitted by Ibramed Equipamentos Medicos (Aventura, US). The FDA issued a Cleared decision on July 24, 2014 after a review of 393 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Ibramed Equipamentos Medicos devices

Submission Details

510(k) Number K131926 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 2013
Decision Date July 24, 2014
Days to Decision 393 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
278d slower than avg
Panel avg: 115d · This submission: 393d
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.