Cleared Traditional

RICH-MAR MODEL II ULTRASOUND

K913981 · Rich-Mar Corp. · Physical Medicine

Nov 1991

Decision

68d

Days

Class 2

Risk

About This 510(k) Submission

K913981 is an FDA 510(k) clearance for the RICH-MAR MODEL 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 November 13, 1991, 68 days after receiving the submission on September 6, 1991. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5300.

Submission Details

510(k) Number	K913981 FDA.gov
FDA Decision	Cleared 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

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