Cleared Traditional

K912202 - RICH-MAR MODEL 25 ULTRASOUND

K912202 is the FDA 510(k) clearance for RICH-MAR MODEL 25 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 120-day FDA review.

K912202 · Rich-Mar Corp. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1991
Decision
120d
Days
Class 2
Risk

K912202 is an FDA 510(k) clearance for the RICH-MAR MODEL 25 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 September 17, 1991 after a review of 120 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 K912202 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 1991
Decision Date September 17, 1991
Days to Decision 120 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
5d slower than avg
Panel avg: 115d · This submission: 120d
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
Devices cleared under the same product code (IMI) and FDA review panel - the closest regulatory comparables to K912202.
ULTRA SX
K923076 · Excel Tech. , Ltd. · Mar 1993
RICH-MAR MODEL 510 ULTRASOUND
K915557 · Rich-Mar Corp. · Mar 1992
RICH-MAR MODEL II ULTRASOUND
K913981 · Rich-Mar Corp. · Nov 1991
RICH-MAR MODEL X ULTRASOUND THERAPY DEVICE
K910708 · Rich-Mar Corp. · May 1991
RICH-MAR MODEL V ULTRASOUND
K904051 · Rich-Mar Corp. · Jan 1991
SONICATOR 720 (MODEL ME720)
K883228 · Mettler Electronics Corp. · Aug 1988