The following data is part of a premarket notification filed by Barron Associates, Inc. with the FDA for Virtual Occupational Therapy Application (vota).
| Device ID | K163245 |
| 510k Number | K163245 |
| Device Name: | Virtual Occupational Therapy Application (VOTA) |
| Classification | Interactive Rehabilitation Exercise Devices |
| Applicant | Barron Associates, Inc. 1410 Sachem Place Suite 202 Charlottesville, VA 22901 |
| Contact | Bruce G. Wilson |
| Correspondent | Bruce G. Wilson Barron Associates, Inc. 1410 Sachem Place Suite 202 Charlottesville, VA 22901 |
| Product Code | LXJ |
| CFR Regulation Number | 890.5360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-11-18 |
| Decision Date | 2017-02-28 |
| Summary: | summary |