The following data is part of a premarket notification filed by Maddak, Inc. with the FDA for Night Trainer.
| Device ID | K834311 |
| 510k Number | K834311 |
| Device Name: | NIGHT TRAINER |
| Classification | Alarm, Conditioned Response Enuresis |
| Applicant | MADDAK, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | KPN |
| CFR Regulation Number | 876.2040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-11-25 |
| Decision Date | 1984-03-30 |