Cleared Traditional

SONICSTIMU COMBO THERAPEUTIC DEVICE

K120217 · Shenzhen Dongdixin Technology Co., Ltd. · Physical Medicine

Nov 2012

Decision

302d

Days

Class 2

Risk

About This 510(k) Submission

K120217 is an FDA 510(k) clearance for the SONICSTIMU COMBO THERAPEUTIC DEVICE, a Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat (Class II — Special Controls, product code IMG), submitted by Shenzhen Dongdixin Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on November 21, 2012, 302 days after receiving the submission on January 24, 2012. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5860.

Submission Details

510(k) Number	K120217 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 24, 2012
Decision Date	November 21, 2012
Days to Decision	302 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	Statement

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