Data / Medical devices / Israel / Healthy.io Ltd.
Healthy.io Ltd.: FDA-registered device maker in Tel Aviv-Yafo, Israel, 2 510(k) clearances
Healthy.io Ltd. is registered with the FDA (registration 3015921024) in Tel Aviv-Yafo, Israel. It lists 4 device types. The FDA files 2 510(k) clearances under its listings, the newest dated September 8, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3015921024
- Address
- 40, Ha-Masger, Tel Aviv-Yafo, Israel, 6721122
- Owner or operator
- Healthy.io Ltd. (10062175)
- Roles
- Manufacturer
- First device listed
- December 26, 2019
- Registered through
- 2026
- Brand names listed
- Minuteful - Kidney Test, Minuteful - kidney test, Minuteful for Wound
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Automated Urinalysis System | KQO | 1 | Manufacturer | accessdata.fda.gov |
| Enzymatic Method, Creatinine | JFY | 2 | Manufacturer | accessdata.fda.gov |
| Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) | JIR | 1 | Manufacturer | accessdata.fda.gov |
| Tape, Camera, Surgical | FXN | 1 | 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 |
|---|---|---|---|---|---|---|
| September 8, 2023 | K222921 | Minuteful-kidney test | JIR | Substantially Equivalent | Healthy.Io, Ltd. | accessdata.fda.gov |
| July 6, 2022 | K210069 | Minuteful - kidney test | JIR | Substantially Equivalent | Healthy.Io, Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)
- All makers of Enzymatic Method, Creatinine
- All makers of Automated Urinalysis System
- All makers of Tape, Camera, Surgical
Updated September 8, 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.