EmField
Stimulator, Muscle, Powered
Zimmer MedizinSysteme GmbH
The following data is part of a premarket notification filed by Zimmer Medizinsysteme Gmbh with the FDA for Emfield.
Pre-market Notification Details
| Device ID | K203488 |
| 510k Number | K203488 |
| Device Name: | EmField |
| Classification | Stimulator, Muscle, Powered |
| Applicant | Zimmer MedizinSysteme GmbH Junkersstrasse 9 Neu-ulm, DE 89231 |
| Contact | Ute Hauss |
| Correspondent | Scott Blood Quality And Regulatory Services 151 Gleasondale Road Stow, MA 01775 |
| Product Code | IPF |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-11-27 |
| Decision Date | 2021-02-19 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04053815078562 | K203488 | 000 |
Trademark Results [EmField]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 EMFIELD 88192506 not registered Live/Pending |
BTL Industries, Inc. 2018-11-13 |
 EMFIELD 87275055 not registered Dead/Abandoned |
ETS-Lindgren Inc. 2016-12-20 |
 EMFIELD 86974380 5111484 Live/Registered |
ETS-Lindgren Inc. 2016-04-13 |
 EMFIELD 86492530 not registered Dead/Abandoned |
ETS-Lindgren Inc. 2014-12-30 |
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