Cleared Traditional

K913981 - RICH-MAR MODEL II ULTRASOUND

K913981 is the FDA 510(k) clearance for RICH-MAR MODEL 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 68-day FDA review.

K913981 · Rich-Mar Corp. · Physical Medicine device
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Nov 1991
Decision
68d
Days
Class 2
Risk

K913981 is an FDA 510(k) clearance for the RICH-MAR MODEL 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 November 13, 1991 after a review of 68 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Rich-Mar Corp. devices

Submission Details

510(k) Number K913981 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 1991
Decision Date November 13, 1991
Days to Decision 68 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
47d faster than avg
Panel avg: 115d · This submission: 68d
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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