Data / Medical devices / United States / Zbeats, Inc
Zbeats, Inc: FDA-registered device maker in Stony Brook, NY, United States, 1 510(k) clearance
Zbeats, Inc is registered with the FDA (registration 3031570367) in Stony Brook, NY, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated July 10, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3031570367
- Address
- 1500 Stony Brook Rd, Stony Brook, NY, United States, 11794
- Owner or operator
- ZBeats, Inc (10095742)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- April 22, 2026
- Registered through
- 2026
- Brand names listed
- ZBPro Diagnostic
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electrocardiograph | DPS | 2 | Complaint file establishment, 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 |
|---|---|---|---|---|---|---|
| July 10, 2025 | K243252 | ZBPro Diagnostic | DPS | Substantially Equivalent | Zbeats, Inc. | accessdata.fda.gov |
Compare with other makers
Updated July 10, 2025. 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.