The following data is part of a premarket notification filed by Zimmer Medizinsysteme Gmbh with the FDA for Emfieldpro.
| Device ID | K182963 |
| 510k Number | K182963 |
| Device Name: | EmFieldPro |
| Classification | Stimulator, Muscle, Powered, For Muscle Conditioning |
| Applicant | Zimmer MedizinSysteme GmbH Junkersstrasse 9 Neu-ulm, DE 89231 |
| Contact | Ute Hauss |
| Correspondent | Scott Blood Quality And Regulatory Services 22 Nichols Street #2 Salem, MA 01970 |
| Product Code | NGX |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-10-25 |
| Decision Date | 2019-06-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04053815074151 | K182963 | 000 |