ViMove

Electromyograph, Diagnostic

DorsaVi Ltd.

The following data is part of a premarket notification filed by Dorsavi Ltd. with the FDA for Vimove.

Pre-market Notification Details

• Device ID: K142494
• 510k Number: K142494
• Device Name: ViMove
• Classification: Electromyograph, Diagnostic
• Applicant: dorsaVi Ltd. Level 1, 120 Jolimont Road East Melbourne, AU 3002
• Contact: Dan Ronchi
• Correspondent: Bosmat Friedman; MJ RAC 1208-12 Rockford Rd. Toronto, CA M2r 3a2
• Product Code: IKN
• Subsequent Product Code: HCC
• Subsequent Product Code: KQX
• CFR Regulation Number: 890.1375 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2014-09-05
• Decision Date: 2015-05-28