Data / Medical devices / Israel / Saliwell Ltd.
Saliwell Ltd.: FDA-registered device maker in Harutzim Central, Israel, 3 510(k) clearances
Saliwell Ltd. is registered with the FDA (registration 3015282800) in Harutzim Central, Israel. It lists 2 device types. The FDA files 3 510(k) clearances under its listings, the newest dated December 13, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3015282800
- Address
- 3A Hatamar St., Harutzim Central, Israel, 6091700
- Owner or operator
- Saliwell Ltd. (10059893)
- Roles
- Manufacturer
- First device listed
- March 5, 2019
- Registered through
- 2026
- Brand names listed
- SaliPen
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Over The Counter Electrical Salivary Stimulatory System | QTT | 2 | Manufacturer | accessdata.fda.gov |
| Stimulator, Salivary System | LTF | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 13, 2023 | K232063 | SaliPen | QTT | Substantially Equivalent | Saliwell , Ltd. | accessdata.fda.gov |
| August 30, 2022 | K220618 | SaliPen | QTT | Substantially Equivalent | Saliwell , Ltd. | accessdata.fda.gov |
| November 6, 2018 | K180838 | SaliPen | LTF | Substantially Equivalent | Saliwell , Ltd. | accessdata.fda.gov |
Updated December 13, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.