Cleared Traditional

K952536 - SONO 5

K952536 is an FDA 510(k) clearance for SONO 5, manufactured by Zimmer Elektromedizin GmbH. The device is a Class 2 Physical Medicine device with 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

FDA 510(k) Submission Details - K952536

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
Combination Product No
PCCP Authorized No
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.

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 63
Devices cleared under the same product code (IMI) and FDA review panel - the closest regulatory comparables to K952536.
DYNATRON 125 ULTRASOUND
K961250 · Dynatronics Corp. · Aug 1996
CUSHMAN MANUFACTURING, INC. ULTRA 6.0.
K960802 · Cushman Mfg., Inc. · Jun 1996
MATRIX MICROSON 410
K954136 · Matrix Biokinetics, Inc. · Apr 1996
RICH-MAR US-II ULTRASOUND
K950564 · Rich-Mar Corp. · May 1995
INTELECT 222 P
K930307 · Chattanooga Group, Inc. · Jul 1993
SONOPULS 590
K920983 · Henley Intl. · Mar 1993