Livia

Stimulator, Nerve, Transcutaneous, Over-the-counter

LIFECARE LTD.

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

Pre-market Notification Details

• Device ID: K163153
• 510k Number: K163153
• Device Name: Livia
• Classification: Stimulator, Nerve, Transcutaneous, Over-the-counter
• Applicant: LIFECARE LTD. ZIPORI ST.2 Tiberias, IL 1424602
• Contact: Amnon Nahum Sharon
• Correspondent: Irving L. Wiesen; COHEN, TAUBER, SPIEVACK & WAGNER 420 LEXINGTON AVENUE-SUITE 2400 New York, NY 10170
• Product Code: NUH
• CFR Regulation Number: 882.5890 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-11-10
• Decision Date: 2017-06-28
• Summary: summary