Cleared Traditional

US-101L, US-103S

K112520 · Ito Co., Ltd. · Physical Medicine

Oct 2011

Decision

56d

Days

Class 2

Risk

About This 510(k) Submission

K112520 is an FDA 510(k) clearance for the US-101L, US-103S, a Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat (Class II — Special Controls, product code IMI), submitted by Ito Co., Ltd. (Tokyo, JP). The FDA issued a Cleared decision on October 26, 2011, 56 days after receiving the submission on August 31, 2011. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5300.

Submission Details

510(k) Number	K112520 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 31, 2011
Decision Date	October 26, 2011
Days to Decision	56 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