Cleared Traditional

K000593 - SONIC, MODEL SO-100

K000593 is an FDA 510(k) clearance for SONIC, manufactured by Metron Medical Australia, Pty, Ltd.. The device is a Class 2 Physical Medicine device with product code IMI cleared through the Traditional 510(k) pathway after a 164-day FDA review.

K000593 · Metron Medical Australia, Pty, Ltd. · Physical Medicine device
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Aug 2000
Decision
164d
Days
Class 2
Risk

K000593 is an FDA 510(k) clearance for the SONIC, MODEL SO-100. Classified as Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat (product code IMI), Class II - Special Controls.

Submitted by Metron Medical Australia, Pty, Ltd. (Carrum Downs, AU). The FDA issued a Cleared decision on August 4, 2000 after a review of 164 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.

FDA 510(k) Submission Details - K000593

510(k) Number K000593 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 2000
Decision Date August 04, 2000
Days to Decision 164 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
48d slower than avg
Panel avg: 116d · This submission: 164d
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 77
Devices cleared under the same product code (IMI) and FDA review panel - the closest regulatory comparables to K000593.
SONIC MODEL SO-300
K010102 · Metron Medical Australia, Pty, Ltd. · Feb 2001
SW ULTRASOUND, MODELS 331, 311, 333
K991613 · Starbene · Dec 2000
ENRAF-NONIUS SONOPULS 190 SYSTEM
K000084 · Henley Healthcare, Inc. · Aug 2000
ACCUSONIC PLUS, MODEL AP-100
K001370 · Metron Medical Australia, Pty, Ltd. · Jul 2000
NATURE'S CHEMIST PAIN RELIEF OINTMENT AND THERAPEUTIC ULTRASOUND COUPLING AGENT
K000604 · Naturopathic Laboratories International, Inc. · May 2000
EXONIX
K984199 · Fibra Sonics, Inc. · Feb 1999
K000593 · SONIC, MODEL SO-100
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