Cleared Special

WINSTIM

K102190 · Johari Digital Healthcare , Ltd. · Physical Medicine

Mar 2011

Decision

226d

Days

Class 2

Risk

About This 510(k) Submission

K102190 is an FDA 510(k) clearance for the WINSTIM, a Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat (Class II — Special Controls, product code IMG), submitted by Johari Digital Healthcare , Ltd. (Jodhpur ,Rajasthan, IN). The FDA issued a Cleared decision on March 17, 2011, 226 days after receiving the submission on August 3, 2010. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5860.

Submission Details

510(k) Number	K102190 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 03, 2010
Decision Date	March 17, 2011
Days to Decision	226 days
Submission Type	Special
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