Therapeutic devices · 21 CFR 872 Subpart F
Over the Counter Electrical Salivary Stimulatory System
Over the Counter Device intended to electrically stimulate a relative increase in saliva production
- Companies listing it
- 11 makers
- Brands and models
- 1
- 510(k) clearances
- 22 in five years
- FDA name
- Over The Counter Electrical Salivary Stimulatory System
510(k) clearances per year, 1976–2026
Companies that list QTT
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 |
|---|---|---|---|
| 13 Dec 2023 | K232063 | SaliPen | Saliwell Ltd. |
| 30 Aug 2022 | K220618 | SaliPen | Saliwell Ltd. |
Official records: FDA product classification for QTT · 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