The following data is part of a premarket notification filed by Institute Of Logopedics with the FDA for Wearable Twenty-four Channel Vibrotactile Vocoder.
| Device ID | K862471 |
| 510k Number | K862471 |
| Device Name: | WEARABLE TWENTY-FOUR CHANNEL VIBROTACTILE VOCODER |
| Classification | Hearing Aid, Tactile |
| Applicant | INSTITUTE OF LOGOPEDICS C/O MEDICAL DEVICE CONSULTANTS 45 WEST STREET, SUITE 2 Attleboro, MA 02703 |
| Contact | William Morton |
| Correspondent | William Morton INSTITUTE OF LOGOPEDICS C/O MEDICAL DEVICE CONSULTANTS 45 WEST STREET, SUITE 2 Attleboro, MA 02703 |
| Product Code | LRA |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-06-30 |
| Decision Date | 1986-09-12 |