The following data is part of a premarket notification filed by Sanwa Components Usa, Inc. with the FDA for My Beat Powered Toothbrush.
| Device ID | K941209 |
| 510k Number | K941209 |
| Device Name: | MY BEAT POWERED TOOTHBRUSH |
| Classification | Toothbrush, Powered |
| Applicant | SANWA COMPONENTS USA, INC. 6540 LUSK BLVD. #C-265 San Diego, CA 92121 |
| Contact | Jay Stup |
| Correspondent | Jay Stup SANWA COMPONENTS USA, INC. 6540 LUSK BLVD. #C-265 San Diego, CA 92121 |
| Product Code | JEQ |
| CFR Regulation Number | 872.6865 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-03-14 |
| Decision Date | 1994-06-16 |