Therm-X

Massager, Powered Inflatable Tube

Zenith Technical Innovations

The following data is part of a premarket notification filed by Zenith Technical Innovations with the FDA for Therm-x.

Pre-market Notification Details

• Device ID: K193550
• 510k Number: K193550
• Device Name: Therm-X
• Classification: Massager, Powered Inflatable Tube
• Applicant: Zenith Technical Innovations 1396 St. Paul Ave. Gurnee, IL 60031
• Contact: Greg Binversie
• Correspondent: Rita King; MethodSense, Inc. 1 Copley Parkway Suite 410 Morrisville, NC 27560
• Product Code: IRP
• Subsequent Product Code: ILO
• Subsequent Product Code: JOW
• CFR Regulation Number: 890.5650 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2019-12-20
• Decision Date: 2020-02-28