Cleared Traditional

ComboRehab

K150436 · Shenzhen Dongdixin Technology Co., Ltd. · Physical Medicine

Nov 2015

Decision

267d

Days

Class 2

Risk

About This 510(k) Submission

K150436 is an FDA 510(k) clearance for the ComboRehab, 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 13, 2015, 267 days after receiving the submission on February 19, 2015. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5860.

Submission Details

510(k) Number	K150436 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 19, 2015
Decision Date	November 13, 2015
Days to Decision	267 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	Summary PDF

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