ThermoPro

Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat

Zimmer MedizinSysteme GmbH

The following data is part of a premarket notification filed by Zimmer Medizinsysteme Gmbh with the FDA for Thermopro.

Pre-market Notification Details

• Device ID: K161862
• 510k Number: K161862
• Device Name: ThermoPro
• Classification: Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat
• Applicant: Zimmer MedizinSysteme GmbH Junkersstrasse 9 Neu-ulm, DE 89231
• Contact: Armin Petraschka
• Correspondent: Scott Blood; QUALITY & REGULATORY CONSULTING 22 Nichols Street #2 Salem, MA 01970
• Product Code: IMJ
• CFR Regulation Number: 890.5290 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-07-06
• Decision Date: 2016-11-14
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
04053815055174	K161862	000