Cleared Traditional

K900189 - CURAPULS 403 DIATHERMY UNIT
(FDA 510(k) Clearance)

K900189 · Henley Intl. · Physical Medicine

Sep 1990

Decision

245d

Days

Class 2

Risk

K900189 is an FDA 510(k) clearance for the CURAPULS 403 DIATHERMY UNIT, a Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat (Class II — Special Controls, product code IMG), submitted by Henley Intl. (Sugar Land, US). The FDA issued a Cleared decision on September 18, 1990, 245 days after receiving the submission on January 16, 1990. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5860.

Submission Details

510(k) Number	K900189 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 16, 1990
Decision Date	September 18, 1990
Days to Decision	245 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	—

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