The following data is part of a premarket notification filed by Emjoi Action Usa, Ltd. with the FDA for Powered Toothbrush.
| Device ID | K970381 |
| 510k Number | K970381 |
| Device Name: | POWERED TOOTHBRUSH |
| Classification | Toothbrush, Powered |
| Applicant | EMJOI ACTION USA, LTD. 7-B OLD COLONY DR. Westford, MA 01886 |
| Contact | James R Marshall, Ph.d. |
| Correspondent | James R Marshall, Ph.d. EMJOI ACTION USA, LTD. 7-B OLD COLONY DR. Westford, MA 01886 |
| Product Code | JEQ |
| CFR Regulation Number | 872.6865 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-02-03 |
| Decision Date | 1997-04-18 |