Cleared Traditional

K950564 - RICH-MAR US-II ULTRASOUND

K950564 is the FDA 510(k) clearance for RICH-MAR US-II ULTRASOUND by Rich-Mar Corp.. It is a Class 2 Physical Medicine device (product code IMI) cleared through the Traditional 510(k) pathway after a 96-day FDA review.

K950564 · Rich-Mar Corp. · Physical Medicine device
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May 1995
Decision
96d
Days
Class 2
Risk

K950564 is an FDA 510(k) clearance for the RICH-MAR US-II ULTRASOUND. Classified as Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat (product code IMI), Class II - Special Controls.

Submitted by Rich-Mar Corp. (Inola, US). The FDA issued a Cleared decision on May 15, 1995 after a review of 96 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 Rich-Mar Corp. devices

Submission Details

510(k) Number K950564 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 1995
Decision Date May 15, 1995
Days to Decision 96 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
19d faster than avg
Panel avg: 115d · This submission: 96d
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 31
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