9Line
Cable, Transducer And Electrode, Patient, (including Connector)
Energetic Designs, Inc.
The following data is part of a premarket notification filed by Energetic Designs, Inc. with the FDA for 9line.
Pre-market Notification Details
| Device ID | K211941 |
| 510k Number | K211941 |
| Device Name: | 9Line |
| Classification | Cable, Transducer And Electrode, Patient, (including Connector) |
| Applicant | Energetic Designs, Inc. 3037 Grizzly Peak Dr. Broomfield, CO 80023 |
| Contact | Kathy Fortin |
| Correspondent | John F. Gillespy FDA 510k Consultants, LLC 1100 Del Lago Circle #104 Palm Beach Gardens, FL 33410 |
| Product Code | DSA |
| CFR Regulation Number | 870.2900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-06-23 |
| Decision Date | 2022-01-27 |
Trademark Results [9Line]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 9LINE 90815469 not registered Live/Pending |
Rising Eagle Medical LLC 2021-07-07 |
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