VIMOVE

Electromyograph, Diagnostic

DORSA VI PTY. LTD

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

Pre-market Notification Details

• Device ID: K131094
• 510k Number: K131094
• Device Name: VIMOVE
• Classification: Electromyograph, Diagnostic
• Applicant: DORSA VI PTY. LTD 1914 J N PEASE PLACE Charlotte, NC 28262
• Contact: Shoshana Friedman
• Correspondent: Shoshana Friedman; DORSA VI PTY. LTD 1914 J N PEASE PLACE Charlotte, NC 28262
• 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: 2013-04-18
• Decision Date: 2014-07-11
• Summary: summary