Data / Medical devices / Israel / Xrhealth R&D Ltd.
Xrhealth R&D Ltd.: FDA-registered device maker in Tel-Aviv Tel Aviv, Israel, 1 510(k) clearance
Xrhealth R&D Ltd. is registered with the FDA (registration 3014153685) in Tel-Aviv Tel Aviv, Israel. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated May 9, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014153685
- Address
- Schoken 32, Tel-Aviv Tel Aviv, Israel, 6105101
- Owner or operator
- XRHealth IL Ltd. (10056292)
- Roles
- Manufacturer
- First device listed
- November 26, 2017
- Registered through
- 2026
- Brand names listed
- Stanza, XRBehavior VRET-910 (Expose), XRBehavior VRFR-930 (First Resort), XRBehavior VRMM-920 (Mind&Motion), XRBehavior VRSO-940 (Step Out), XRCogni CT-620 (Memorize), XRCogni CT-630 Koji Quest, XRCogni MC-320 (Color Match) and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Computerized Behavioral Therapy Device For The Treatment Of Fibromyalgia Symptoms | QWI | 2 | Manufacturer | accessdata.fda.gov |
| Computerized Cognitive Assessment Aid, Exempt | PTY | 2 | Manufacturer | accessdata.fda.gov |
| Exerciser, Measuring | ISD | 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 |
|---|---|---|---|---|---|---|
| May 9, 2023 | DEN220083 | Stanza | QWI | Unknown | Swing Therapeutics, Inc. | accessdata.fda.gov |
Compare with other makers
Updated May 9, 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.