The following data is part of a premarket notification filed by Prentke Romich Co. with the FDA for Alpha Talker.
| Device ID | K935317 |
| 510k Number | K935317 |
| Device Name: | ALPHA TALKER |
| Classification | Wheelchair, Powered |
| Applicant | PRENTKE ROMICH CO. 1022 HEYL RD. Wooster, OH 44691 |
| Contact | Dave Hershberger |
| Correspondent | Dave Hershberger PRENTKE ROMICH CO. 1022 HEYL RD. Wooster, OH 44691 |
| Product Code | ITI |
| CFR Regulation Number | 890.3860 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-11-04 |
| Decision Date | 1994-03-28 |