Healy

Stimulator, Nerve, Transcutaneous, Over-the-counter

TimeWaver Production GmbH

The following data is part of a premarket notification filed by Timewaver Production Gmbh with the FDA for Healy.

Pre-market Notification Details

• Device ID: K191075
• 510k Number: K191075
• Device Name: Healy
• Classification: Stimulator, Nerve, Transcutaneous, Over-the-counter
• Applicant: TimeWaver Production GmbH Schloss Kranzlin Darritzer Strab 6 Kranzlin, DE 16818
• Contact: Martin Wittmann
• Correspondent: Douglas Herrington; Herrington Consulting LLC 2885 Sanford Ave, SW #43083 Grandville, MI 49418
• Product Code: NUH
• CFR Regulation Number: 882.5890 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2019-04-23
• Decision Date: 2019-11-22
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
04251784206034	K191075	000
04251784906033	K191075	000
04251784906088	K191075	000