Cleared Traditional

K872393 - SONOPULS 463

K872393 is the FDA 510(k) clearance for SONOPULS 463 by Henley Intl.. It is a Class 2 Physical Medicine device (product code IMI) cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K872393 · Henley Intl. · Physical Medicine device
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Jul 1987
Decision
41d
Days
Class 2
Risk

K872393 is an FDA 510(k) clearance for the SONOPULS 463, ULTRASOUND THERAPY EQUIPMENT. Classified as Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat (product code IMI), Class II - Special Controls.

Submitted by Henley Intl. (Houston, US). The FDA issued a Cleared decision on July 23, 1987 after a review of 41 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 Henley Intl. devices

Submission Details

510(k) Number K872393 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 1987
Decision Date July 23, 1987
Days to Decision 41 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
74d faster than avg
Panel avg: 115d · This submission: 41d
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 24
Devices cleared under the same product code (IMI) and FDA review panel - the closest regulatory comparables to K872393.
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US 610
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INTELECT 200 THERAPEUTIC ULTRASOUND
K841446 · Chattanooga Group, Inc. · May 1984