Cleared Traditional

RICH-MAR MODEL 510 ULTRASOUND

K915557 · Rich-Mar Corp. · Physical Medicine

Mar 1992

Decision

90d

Days

Class 2

Risk

About This 510(k) Submission

K915557 is an FDA 510(k) clearance for the RICH-MAR MODEL 510 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 March 10, 1992, 90 days after receiving the submission on December 11, 1991. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5300.

Submission Details

510(k) Number	K915557 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 11, 1991
Decision Date	March 10, 1992
Days to Decision	90 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