Cleared Traditional

RICH-MAR MODEL V ULTRASOUND

K904051 · Rich-Mar Corp. · Physical Medicine

Jan 1991

Decision

132d

Days

Class 2

Risk

About This 510(k) Submission

K904051 is an FDA 510(k) clearance for the RICH-MAR MODEL V 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 January 14, 1991, 132 days after receiving the submission on September 4, 1990. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5300.

Submission Details

510(k) Number	K904051 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 04, 1990
Decision Date	January 14, 1991
Days to Decision	132 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	—

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