CoolTone
Stimulator, Muscle, Powered, For Muscle Conditioning
Zimmer MedizinSysteme GmbH
The following data is part of a premarket notification filed by Zimmer Medizinsysteme Gmbh with the FDA for Cooltone.
Pre-market Notification Details
| Device ID | K192940 |
| 510k Number | K192940 |
| Device Name: | CoolTone |
| Classification | Stimulator, Muscle, Powered, For Muscle Conditioning |
| Applicant | Zimmer MedizinSysteme GmbH Junkerstrasse 9 Neu-ulm, DE 89231 |
| Contact | Ute Hauss |
| Correspondent | Scott Blood Quality And Regulatory Services 151 Glensondale Road Stow, MA 01775 |
| Product Code | NGX |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-10-18 |
| Decision Date | 2019-11-15 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04053815076698 | K192940 | 000 |
Trademark Results [CoolTone]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 COOLTONE 98739920 not registered Live/Pending |
Sage Electrochromics, Inc. 2024-09-09 |
 COOLTONE 88266308 not registered Live/Pending |
Zeltiq Aesthetics, Inc. 2019-01-17 |
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