Cleared Traditional

K970131 - ORTHOSONICS DUO-SON ULTRASOUND DIATHERMY DEVICE

K970131 is an FDA 510(k) clearance for ORTHOSONICS DUO-SON ULTRASOUND DIATHERM..., manufactured by C.L. Mcintosh & Assoc., Inc.. The device is a Class 2 Physical Medicine device with product code IMI cleared through the Traditional 510(k) pathway after a 153-day FDA review.

K970131 · C.L. Mcintosh & Assoc., Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1997
Decision
153d
Days
Class 2
Risk

K970131 is an FDA 510(k) clearance for the ORTHOSONICS DUO-SON ULTRASOUND DIATHERMY DEVICE. Classified as Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat (product code IMI), Class II - Special Controls.

Submitted by C.L. Mcintosh & Assoc., Inc. (Rockville, US). The FDA issued a Cleared decision on June 16, 1997 after a review of 153 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 C.L. Mcintosh & Assoc., Inc. devices

FDA 510(k) Submission Details - K970131

510(k) Number K970131 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 14, 1997
Decision Date June 16, 1997
Days to Decision 153 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
38d slower than avg
Panel avg: 115d · This submission: 153d
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 49
Devices cleared under the same product code (IMI) and FDA review panel - the closest regulatory comparables to K970131.
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
DYNATRON 125 ULTRASOUND
K961250 · Dynatronics Corp. · Aug 1996
RICH-MAR US-II ULTRASOUND
K950564 · Rich-Mar Corp. · May 1995
INTELECT 222 P
K930307 · Chattanooga Group, Inc. · Jul 1993