Cleared Traditional

RICH-MAR MODEL 25 ULTRASOUND

K912202 · Rich-Mar Corp. · Physical Medicine

Sep 1991

Decision

120d

Days

Class 2

Risk

About This 510(k) Submission

K912202 is an FDA 510(k) clearance for the RICH-MAR MODEL 25 ULTRASOUND, a Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat (Class II — Special Controls, product code IMI), submitted by Rich-Mar Corp. (Inola, US). The FDA issued a Cleared decision on September 17, 1991, 120 days after receiving the submission on May 20, 1991. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5300.

Submission Details

510(k) Number	K912202 FDA.gov
FDA Decision	Cleared 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

Device Classification

Product Code	IMI — Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 890.5300