emField 5038
GUDID 04053815078562
Zimmer MedizinSysteme GmbH
Deep-tissue electromagnetic stimulation system, professional| Primary Device ID | 04053815078562 |
| NIH Device Record Key | 8507e270-2be0-40d5-b375-309e12fff2dc |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | emField |
| Version Model Number | 5038 |
| Catalog Number | 5038 |
| Company DUNS | 316111251 |
| Company Name | Zimmer MedizinSysteme GmbH |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | (800) 327-3576 |
| info@zimmerusa.com | |
| Phone | (800) 327-3576 |
| info@zimmerusa.com | |
| Phone | (800) 327-3576 |
| info@zimmerusa.com | |
| Phone | (800) 327-3576 |
| info@zimmerusa.com | |
| Phone | (800) 327-3576 |
| info@zimmerusa.com | |
| Phone | (800) 327-3576 |
| info@zimmerusa.com | |
| Phone | (800) 327-3576 |
| info@zimmerusa.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04053815078562 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K203488
FDA Product Code
| IPF | Stimulator, Muscle, Powered |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-05-19 |
| Device Publish Date | 2022-05-11 |
Devices Manufactured by Zimmer MedizinSysteme GmbH
| 04053815087410 - ZStim | 2024-08-06 |
| 04053815086369 - ZShape | 2024-07-29 |
| 04053815087229 - Cryo 7 | 2024-06-04 |
| 04053815076711 - MFG-05 | 2023-10-24 |
| 04053815081296 - ThermoTK | 2023-06-13 |
| 04053815083344 - clTrac | 2023-06-13 |
| 04053815078562 - emField | 2022-05-19 |
| 04053815078562 - emField | 2022-05-19 |
| 04053815080848 - Cryo 7 | 2022-03-09 |
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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