The following data is part of a premarket notification filed by Multicept A/s with the FDA for Multi Care Therapeutic Vibrator.
| Device ID | K010096 |
| 510k Number | K010096 |
| Device Name: | MULTI CARE THERAPEUTIC VIBRATOR |
| Classification | Vibrator For Therapeutic Use, Genital |
| Applicant | MULTICEPT A/S LYNGSOE ALLE 3,1 Hoersholm, DK 2970 |
| Contact | Klaus Vammen |
| Correspondent | Klaus Vammen MULTICEPT A/S LYNGSOE ALLE 3,1 Hoersholm, DK 2970 |
| Product Code | KXQ |
| CFR Regulation Number | 884.5960 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-01-11 |
| Decision Date | 2001-03-05 |