Cleared Traditional

RICH-MAR MODEL X ULTRASOUND THERAPY DEVICE

K910708 · Rich-Mar Corp. · Physical Medicine

May 1991

Decision

90d

Days

Class 2

Risk

About This 510(k) Submission

K910708 is an FDA 510(k) clearance for the RICH-MAR MODEL X ULTRASOUND THERAPY DEVICE, 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 May 21, 1991, 90 days after receiving the submission on February 20, 1991. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5300.

Submission Details

510(k) Number	K910708 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 20, 1991
Decision Date	May 21, 1991
Days to Decision	90 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	—

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