Cleared Traditional

K851937 - SONOMED 4

K851937 is the FDA 510(k) clearance for SONOMED 4 by Robert Bosch Corp.. It is a Class 2 Physical Medicine device (product code IMI) cleared through the Traditional 510(k) pathway after a 93-day FDA review.

K851937 · Robert Bosch Corp. · Physical Medicine device
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Jul 1985
Decision
93d
Days
Class 2
Risk

K851937 is an FDA 510(k) clearance for the SONOMED 4. Classified as Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat (product code IMI), Class II - Special Controls.

Submitted by Robert Bosch Corp. (St. James, US). The FDA issued a Cleared decision on July 17, 1985 after a review of 93 days - within the typical 510(k) review window.

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 Robert Bosch Corp. devices

Submission Details

510(k) Number K851937 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 1985
Decision Date July 17, 1985
Days to Decision 93 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
22d faster than avg
Panel avg: 115d · This submission: 93d
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
Devices cleared under the same product code (IMI) and FDA review panel - the closest regulatory comparables to K851937.
MODIFIED SONICATOR 720, MODEL ME720
K880602 · Mettler Electronics Corp. · Feb 1988
SONICATOR 720 (MODEL ME720)
K873812 · Mettler Electronics Corp. · Dec 1987
SONOPULS 463, ULTRASOUND THERAPY EQUIPMENT
K872393 · Henley Intl. · Jul 1987
SONICATOR 705 MODEL ME 705
K851397 · Mettler Electronics Corp. · Jul 1985
US 610
K844036 · Rich-Mar Corp. · Nov 1984
INTELECT 205 PORTABLE ULTRASOUND UNIT
K841445 · Chattanooga Group, Inc. · May 1984