The following data is part of a premarket notification filed by Ito Co., Ltd. with the FDA for D Function.
| Device ID | K203525 |
| 510k Number | K203525 |
| Device Name: | D Function |
| Classification | Stimulator, Muscle, Powered, Dental |
| Applicant | ITO CO., LTD. 3-1-8 Sakae-cho Kawaguchi-shi, JP 332-0017 |
| Contact | Takeshi Kobayashi |
| Correspondent | Takeshi Kobayashi ITO CO., LTD. 3-1-8 Sakae-cho Kawaguchi-shi, JP 332-0017 |
| Product Code | NUW |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-12-01 |
| Decision Date | 2021-05-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04983087012394 | K203525 | 000 |