Therapeutic devices · 21 CFR 872 Subpart F
Salivary System Stimulator
FDA device type “Stimulator, Salivary System”.
- Companies listing it
- 11 makers
- Brands and models
- 1
- 510(k) clearances
- 20 in five years
- FDA name
- Stimulator, Salivary System
510(k) clearances per year, 1976–2026
Companies that list LTF
1 company currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Saliwell Ltd. | Israel | Maker | SaliPen | 4 | 2023 |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 6 Nov 2018 | K180838 | SaliPen | Saliwell Ltd. |
| 17 Feb 2017 | K160799 | GenNarino | Saliwell Ltd. |
Official records: FDA product classification for LTF · 21 CFR 872.5560.
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026