The following data is part of a premarket notification filed by Kea Products Ltd with the FDA for Klinly Ultrasonic Tongue Cleaner.
| Device ID | K181986 |
| 510k Number | K181986 |
| Device Name: | Klinly Ultrasonic Tongue Cleaner |
| Classification | Powered Tongue Scraper |
| Applicant | KEA Products Ltd 10C, Meyer Ind. Bldg, 2 Chong Yip Street Kwun Tong, HK 00000 |
| Contact | Michael Schmidt |
| Correspondent | Robert T. Bock Robert T. Bock Consultancy LLC 66 Drovers Lane Brewster, NY 10509 |
| Product Code | QIA |
| CFR Regulation Number | 872.6865 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-07-25 |
| Decision Date | 2019-09-06 |
| Summary: | summary |