Cleared Traditional

SW-180 SHORTWAVE THERAPY UNIT

K022846 · Ito Co., Ltd. · Physical Medicine

Jan 2003

Decision

154d

Days

Class 2

Risk

About This 510(k) Submission

K022846 is an FDA 510(k) clearance for the SW-180 SHORTWAVE THERAPY UNIT, a Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat (Class II — Special Controls, product code IMJ), submitted by Ito Co., Ltd. (Brookeville, US). The FDA issued a Cleared decision on January 28, 2003, 154 days after receiving the submission on August 27, 2002. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5290.

Submission Details

510(k) Number	K022846 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 27, 2002
Decision Date	January 28, 2003
Days to Decision	154 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	Summary PDF

Device Classification

Product Code	IMJ — Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 890.5290