Cleared Traditional

MODEL 25 THERAPEUTIC ULTRASOUND -- MODIFIED

K923797 · Rich-Mar Corp. · Physical Medicine

Nov 1992

Decision

101d

Days

Class 2

Risk

About This 510(k) Submission

K923797 is an FDA 510(k) clearance for the MODEL 25 THERAPEUTIC ULTRASOUND -- MODIFIED, a Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat (Class II — Special Controls, product code IMG), submitted by Rich-Mar Corp. (Inola, US). The FDA issued a Cleared decision on November 6, 1992, 101 days after receiving the submission on July 28, 1992. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5860.

Submission Details

510(k) Number	K923797 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 28, 1992
Decision Date	November 06, 1992
Days to Decision	101 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	Statement

Device Classification

Product Code	IMG — Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 890.5860