The following data is part of a premarket notification filed by Alimed, Inc. with the FDA for Mini Vibrator.
| Device ID | K920487 |
| 510k Number | K920487 |
| Device Name: | MINI VIBRATOR |
| Classification | Vibrator, Therapeutic |
| Applicant | ALIMED, INC. 297 HIGH ST. Dedham, MA 02026 |
| Contact | Jonathan C Bertz |
| Correspondent | Jonathan C Bertz ALIMED, INC. 297 HIGH ST. Dedham, MA 02026 |
| Product Code | IRO |
| CFR Regulation Number | 890.5975 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-01-30 |
| Decision Date | 1992-02-18 |