WINSTIM

Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat

JOHARI DIGITAL HEALTHCARE, LTD.

The following data is part of a premarket notification filed by Johari Digital Healthcare, Ltd. with the FDA for Winstim.

Pre-market Notification Details

• Device ID: K102190
• 510k Number: K102190
• Device Name: WINSTIM
• Classification: Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat
• Applicant: JOHARI DIGITAL HEALTHCARE, LTD. G-582,583, E.P.I.P. BORANADA Jodhpur ,rajasthan, IN 342008
• Contact: Nisha Johari
• Correspondent: Nisha Johari; JOHARI DIGITAL HEALTHCARE, LTD. G-582,583, E.P.I.P. BORANADA Jodhpur ,rajasthan, IN 342008
• Product Code: IMG
• Subsequent Product Code: GZI
• Subsequent Product Code: GZJ
• Subsequent Product Code: IPF
• CFR Regulation Number: 890.5860 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2010-08-03
• Decision Date: 2011-03-17
• Summary: summary