Cleared Traditional

K960802 - CUSHMAN MANUFACTURING, INC. ULTRA 6.0.

K960802 is an FDA 510(k) clearance for CUSHMAN MANUFACTURING, manufactured by Cushman Mfg., Inc.. The device is a Class 2 Physical Medicine device with product code IMI cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K960802 · Cushman Mfg., Inc. · Physical Medicine device
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Jun 1996
Decision
112d
Days
Class 2
Risk

K960802 is an FDA 510(k) clearance for the CUSHMAN MANUFACTURING, INC. ULTRA 6.0.. Classified as Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat (product code IMI), Class II - Special Controls.

Submitted by Cushman Mfg., Inc. (Long Beach, US). The FDA issued a Cleared decision on June 18, 1996 after a review of 112 days - within the typical 510(k) review window.

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 Cushman Mfg., Inc. devices

FDA 510(k) Submission Details - K960802

510(k) Number K960802 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 1996
Decision Date June 18, 1996
Days to Decision 112 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
3d faster than avg
Panel avg: 115d · This submission: 112d
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 54
Devices cleared under the same product code (IMI) and FDA review panel - the closest regulatory comparables to K960802.
INTELECT LEGEND ULTRASOUND
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ORTHOSONICS DUO-SON ULTRASOUND DIATHERMY DEVICE
K970131 · C.L. Mcintosh & Assoc., Inc. · Jun 1997
DYNATRON 125 ULTRASOUND
K961250 · Dynatronics Corp. · Aug 1996
MATRIX MICROSON 410
K954136 · Matrix Biokinetics, Inc. · Apr 1996
SONO 5
K952536 · Zimmer Elektromedizin GmbH · Mar 1996
RICH-MAR US-II ULTRASOUND
K950564 · Rich-Mar Corp. · May 1995