Cleared Traditional

K920983 - SONOPULS 590

K920983 is the FDA 510(k) clearance for SONOPULS 590 by Henley Intl.. It is a Class 2 Physical Medicine device (product code IMI) cleared through the Traditional 510(k) pathway after a 372-day FDA review.

K920983 · Henley Intl. · Physical Medicine device
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Mar 1993
Decision
372d
Days
Class 2
Risk

K920983 is an FDA 510(k) clearance for the SONOPULS 590. Classified as Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat (product code IMI), Class II - Special Controls.

Submitted by Henley Intl. (Sugar Land, US). The FDA issued a Cleared decision on March 9, 1993 after a review of 372 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Henley Intl. devices

Submission Details

510(k) Number K920983 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 1992
Decision Date March 09, 1993
Days to Decision 372 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
257d slower than avg
Panel avg: 115d · This submission: 372d
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
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