Cleared Traditional

K952536 - SONO 5

K952536 is the FDA 510(k) clearance for SONO 5 by Zimmer Elektromedizin GmbH. It is a Class 2 Physical Medicine device (product code IMI) cleared through the Traditional 510(k) pathway after a 278-day FDA review.

K952536 · Zimmer Elektromedizin GmbH · Physical Medicine device
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Mar 1996
Decision
278d
Days
Class 2
Risk

K952536 is an FDA 510(k) clearance for the SONO 5. Classified as Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat (product code IMI), Class II - Special Controls.

Submitted by Zimmer Elektromedizin GmbH (D7910 Neu-Ulm, DE). The FDA issued a Cleared decision on March 5, 1996 after a review of 278 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 Zimmer Elektromedizin GmbH devices

Submission Details

510(k) Number K952536 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received June 01, 1995
Decision Date March 05, 1996
Days to Decision 278 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
163d slower than avg
Panel avg: 115d · This submission: 278d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 32
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