Data / Medical devices / Israel / SENSIBLE MEDICAL INNOVATIONS Ltd.
SENSIBLE MEDICAL INNOVATIONS Ltd.: FDA-registered device maker in Netanya Central, Israel, 2 510(k) clearances
SENSIBLE MEDICAL INNOVATIONS Ltd. is registered with the FDA (registration 3011773282) in Netanya Central, Israel. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated February 28, 2019. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3011773282
- Address
- Meir Ariel 6, Netanya Central, Israel, 4250364
- Owner or operator
- Sensible Medical Innovations Ltd. (10050447)
- Roles
- Manufacturer
- First device listed
- December 9, 2015
- Registered through
- 2026
- Brand names listed
- ReDS Pro System, ReDS Wearable System (ReDS System)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Plethysmograph, Impedance | DSB | 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 |
|---|---|---|---|---|---|---|
| February 28, 2019 | K180479 | ReDS System | DSB | Substantially Equivalent | Sensible Medical Innovations , Ltd. | accessdata.fda.gov |
| August 6, 2015 | K150095 | ReDs Wearable System | DSB | Substantially Equivalent | Sensible Medical Innovations , Ltd. | accessdata.fda.gov |
Compare with other makers
Updated February 28, 2019. 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.