Cleared Traditional

K850640 - SONOPULS 434 ULTRASOUND THERAPY EQUIPMENT

K850640 is the FDA 510(k) clearance for SONOPULS 434 ULTRASOUND THERAPY EQUIPMENT by Fluidotherapy Corp.. It is a Class 2 Physical Medicine device (product code IMI) cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K850640 · Fluidotherapy Corp. · Physical Medicine device
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May 1985
Decision
84d
Days
Class 2
Risk

K850640 is an FDA 510(k) clearance for the SONOPULS 434 ULTRASOUND THERAPY EQUIPMENT. Classified as Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat (product code IMI), Class II - Special Controls.

Submitted by Fluidotherapy Corp. (Houston, US). The FDA issued a Cleared decision on May 14, 1985 after a review of 84 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Fluidotherapy Corp. devices

Submission Details

510(k) Number K850640 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 1985
Decision Date May 14, 1985
Days to Decision 84 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
31d faster than avg
Panel avg: 115d · This submission: 84d
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 K850640.
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
INTELECT 200 THERAPEUTIC ULTRASOUND
K841446 · Chattanooga Group, Inc. · May 1984