Cleared Traditional

RICH-MAR THERASOUND 6.5 THERAPEUTIC ULTRASOUND

K021483 · Rich-Mar Corp. · Physical Medicine

Sep 2002

Decision

128d

Days

Class 2

Risk

About This 510(k) Submission

K021483 is an FDA 510(k) clearance for the RICH-MAR THERASOUND 6.5 THERAPEUTIC 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 13, 2002, 128 days after receiving the submission on May 8, 2002. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5300.

Submission Details

510(k) Number	K021483 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 08, 2002
Decision Date	September 13, 2002
Days to Decision	128 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