The following data is part of a premarket notification filed by Multicept Aps with the FDA for Ferticare Personal Therapeutic Vibrator.
| Device ID | K955589 |
| 510k Number | K955589 |
| Device Name: | FERTICARE PERSONAL THERAPEUTIC VIBRATOR |
| Classification | Vibrator For Therapeutic Use, Genital |
| Applicant | MULTICEPT APS VALLERODVANGE 2 2960 Rungsted Kyst,denmark, DK |
| Contact | S, K Mcgarvey |
| Correspondent | S, K Mcgarvey MULTICEPT APS VALLERODVANGE 2 2960 Rungsted Kyst,denmark, DK |
| Product Code | KXQ |
| CFR Regulation Number | 884.5960 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-12-07 |
| Decision Date | 1996-04-11 |