Tinearity G1 (6103); Tinearity G1 Adapters x3 (6042)
FDA 510(k) K223694 · Duearity AB
510(k) numberK223694
Submission
- Device name
- Tinearity G1 (6103); Tinearity G1 Adapters x3 (6042)
- Applicant
- Duearity AB
Malmo, SE - Received
- December 9, 2022
- Decision date
- June 30, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KLW – Masker, Tinnitus
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.3400
- Specialty
- Ear, Nose, Throat
Other 510(k)s with product code KLW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260413 | Levo Gen 2 Tinnitus Therapy SystemKLW · Traditional | Levo Medical Corporation | 08/13/2026SE |
| K260614 | Tinnitus TherapyKLW · Special | Sivantos GmbH | 06/10/2026SE |
| K233435 | Peace N Quiet (0.7.0)KLW · Traditional | Pnq Health | 02/27/2024SE |
| K221168 | Tinnitogram Signal GeneratorKLW · Traditional | Goldenear Company, Inc. | 02/01/2023SE |
| K221125 | SilentCloudKLW · Traditional | Aureliym GmbH | 01/04/2023SE |
| K201370 | Multiflex Tinnitus TechnologyKLW · Special | Starkey Laboratories, Inc. | 06/19/2020SE |
| K193303 | Tinnitus Sound Generator ModuleKLW · Special | GN Hearing A/S | 02/20/2020SE |
| K180495 | Tinnitus Sound Generator ModuleKLW · Traditional | GN Hearing A/S | 11/30/2018SE |
| K181586 | Tinnitus Sound Generator ModuleKLW · Special | GN Hearing A/S | 07/13/2018SE |
| K171243 | audifon Tinnitus-ModuleKLW · Abbreviated | Audiofon USA, Inc. | 10/19/2017SE |
Questions and answers
When was Tinearity G1 (6103); Tinearity G1 Adapters x3 (6042) cleared by the FDA?
Tinearity G1 (6103); Tinearity G1 Adapters x3 (6042) (K223694) received a 510(k) decision of Substantially Equivalent on June 30, 2023, 203 days after the submission was received.
What is the product code of K223694?
The FDA product code is KLW – Masker, Tinnitus, a Class II (moderate risk) device regulated under 21 CFR 874.3400.