Cleared Traditional

K000084 - ENRAF-NONIUS SONOPULS 190 SYSTEM

K000084 is an FDA 510(k) clearance for ENRAF-NONIUS SONOPULS 190 SYSTEM, manufactured by Henley Healthcare, Inc.. The device is a Class 2 Physical Medicine device with product code IMI cleared through the Traditional 510(k) pathway after a 205-day FDA review.

K000084 · Henley Healthcare, Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2000
Decision
205d
Days
Class 2
Risk

K000084 is an FDA 510(k) clearance for the ENRAF-NONIUS SONOPULS 190 SYSTEM. Classified as Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat (product code IMI), Class II - Special Controls.

Submitted by Henley Healthcare, Inc. (Sugar Land, US). The FDA issued a Cleared decision on August 4, 2000 after a review of 205 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.

View all Henley Healthcare, Inc. devices

FDA 510(k) Submission Details - K000084

510(k) Number K000084 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 12, 2000
Decision Date August 04, 2000
Days to Decision 205 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
90d slower than avg
Panel avg: 115d · This submission: 205d
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 36
Devices cleared under the same product code (IMI) and FDA review panel - the closest regulatory comparables to K000084.
DYNATRON SOLARIS SERIES, MODELS 705, 706, 708, 709 D880 INFRARED PROBE (OPTIONAL ACCESSORY)
K031329 · Dynatronics Corp. · Oct 2003
RICH-MAR THERASOUND 6.5 THERAPEUTIC ULTRASOUND
K021483 · Rich-Mar Corp. · Sep 2002
SONICATOR PLUS 930, MODEL ME 930
K013192 · Mettler Electronics Corp. · Oct 2001
RICH-MAR US500, US750, US1000 THERAPEUTIC UNLTRASOUND DEVICES
K982544 · Rich-Mar Corp. · Nov 1998
FORTE, MODEL CPS ULTRASOUND
K982829 · Chattanooga Group, Inc. · Nov 1998
INTELECT LEGEND ULTRASOUND
K973024 · Chattanooga Group, Inc. · Nov 1997