The following data is part of a premarket notification filed by Highmark Innovations Inc. Dba Highmark Interactive with the FDA for Eq Balance.
| Device ID | K190735 |
| 510k Number | K190735 |
| Device Name: | EQ Balance |
| Classification | Apparatus, Vestibular Analysis |
| Applicant | Highmark Innovations Inc. DBA Highmark Interactive 1 University Avenue, 3rd Floor Toronto, CA M5j 2pl |
| Contact | Dave Crane |
| Correspondent | E. J. Smith Smith Associates 1468 Harwell Avenue Crofton, MD 21114 |
| Product Code | LXV |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-03-21 |
| Decision Date | 2019-08-16 |