Cleared Traditional

SONOPULS 590

K920983 · Henley Intl. · Physical Medicine

Mar 1993

Decision

372d

Days

Class 2

Risk

About This 510(k) Submission

K920983 is an FDA 510(k) clearance for the SONOPULS 590, a Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat (Class II — Special Controls, product code IMI), submitted by Henley Intl. (Sugar Land, US). The FDA issued a Cleared decision on March 9, 1993, 372 days after receiving the submission on March 2, 1992. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5300.

Submission Details

510(k) Number	K920983 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 02, 1992
Decision Date	March 09, 1993
Days to Decision	372 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