KLW — Masker, Tinnitus Class II
FDA Device Classification
Classification Details
- Product Code
- KLW
- Device Class
- Class II
- Regulation Number
- 874.3400
- Submission Type
- Review Panel
- EN
- Medical Specialty
- Ear, Nose, Throat
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K233435 | pnq health | Peace N Quiet (0.7.0) | February 27, 2024 |
| K223694 | duearity | Tinearity G1 (6103); Tinearity G1 Adapters x3 (6042) | June 30, 2023 |
| K221168 | goldenear company | Tinnitogram Signal Generator | February 1, 2023 |
| K221125 | aureliym | SilentCloud | January 4, 2023 |
| K201370 | starkey laboratories | Multiflex Tinnitus Technology | June 19, 2020 |
| K193303 | gn hearing | Tinnitus Sound Generator Module | February 20, 2020 |
| K180495 | gn hearing | Tinnitus Sound Generator Module | November 30, 2018 |
| K181586 | gn hearing | Tinnitus Sound Generator Module | July 13, 2018 |
| K171243 | audiofon usa | audifon Tinnitus-Module | October 19, 2017 |
| K163094 | jiangsu betterlife medical co | TinniLogic Mobile Tinnitus Management Device | May 17, 2017 |
| K161562 | sound options tinnitus treatments | Sound Options Tinnitus Treatment | September 28, 2016 |
| K161331 | turtle beach corporation | HyperSound Tinnitus Module | August 23, 2016 |
| K151558 | neurotherapies reset | Desyncra for Tinnitus Therapy System, Desyncra for Tinnitus Pro System | January 20, 2016 |
| K151719 | kw ear lab | REVE134 | October 9, 2015 |
| K150014 | sanuthera | Serenity | July 27, 2015 |
| K150171 | gn resound | Tinnitus Sound Generator Module | May 14, 2015 |
| K150065 | soundcure | SoundCure Serenade Tinnitus Treatment System | April 13, 2015 |
| K140845 | otoharmonics | LEVO TINNITUS MASKING SOFTWARE DEVICE | July 18, 2014 |
| K132965 | amplisound hearing products and services | SOLACE SOUND GENERATORS | March 25, 2014 |
| K133308 | oticon | TINNITUS SOUNDSUPPORT | March 18, 2014 |