Cleared Traditional

K130888 - SONOPULSE/ SONOPULSE III

K130888 is an FDA 510(k) clearance for SONOPULSE/ SONOPULSE III, manufactured by Ibramed- Industria Brazileria DE Equipamentos Medi. The device is a Class 2 Physical Medicine device with product code IMI cleared through the Traditional 510(k) pathway after a 286-day FDA review.

K130888 · Ibramed- Industria Brazileria DE Equipamentos Medi · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2014
Decision
286d
Days
Class 2
Risk

K130888 is an FDA 510(k) clearance for the SONOPULSE/ SONOPULSE III. Classified as Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat (product code IMI), Class II - Special Controls.

Submitted by Ibramed- Industria Brazileria DE Equipamentos Medi (Aventura, US). The FDA issued a Cleared decision on January 9, 2014 after a review of 286 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 Ibramed- Industria Brazileria DE Equipamentos Medi devices

FDA 510(k) Submission Details - K130888

510(k) Number K130888 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 2013
Decision Date January 09, 2014
Days to Decision 286 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
171d slower than avg
Panel avg: 115d · This submission: 286d
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 39
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