Cleared Traditional

RICH-MAR US-II ULTRASOUND

K950564 · Rich-Mar Corp. · Physical Medicine

May 1995

Decision

96d

Days

Class 2

Risk

About This 510(k) Submission

K950564 is an FDA 510(k) clearance for the RICH-MAR US-II 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 May 15, 1995, 96 days after receiving the submission on February 8, 1995. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5300.

Submission Details

510(k) Number	K950564 FDA.gov
FDA Decision	Cleared 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

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