Cleared Traditional

Sonopuls 190

K230472 · Enraf-Nonius, B.V. · Physical Medicine

Oct 2023

Decision

244d

Days

Class 2

Risk

About This 510(k) Submission

K230472 is an FDA 510(k) clearance for the Sonopuls 190, a Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat (Class II — Special Controls, product code IMI), submitted by Enraf-Nonius, B.V. (Rotterdam, NL). The FDA issued a Cleared decision on October 24, 2023, 244 days after receiving the submission on February 22, 2023. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5300.

Submission Details

510(k) Number	K230472 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 22, 2023
Decision Date	October 24, 2023
Days to Decision	244 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	Summary PDF

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