Cleared Traditional

RICH-MAR US500, US750, US1000 THERAPEUTIC UNLTRASOUND DEVICES

K982544 · Rich-Mar Corp. · Physical Medicine

Nov 1998

Decision

121d

Days

Class 2

Risk

About This 510(k) Submission

K982544 is an FDA 510(k) clearance for the RICH-MAR US500, US750, US1000 THERAPEUTIC UNLTRASOUND DEVICES, 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 19, 1998, 121 days after receiving the submission on July 21, 1998. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5300.

Submission Details

510(k) Number	K982544 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 21, 1998
Decision Date	November 19, 1998
Days to Decision	121 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