Data / Medical devices / United States / Hello Heart
Hello Heart: FDA-registered device maker in Menlo Park, CA, United States, 1 510(k) clearance
Hello Heart is registered with the FDA (registration 3026567235) in Menlo Park, CA, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated November 22, 2023. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3026567235
- Address
- 545 Middlefield Rd Ste 220, Menlo Park, CA, United States, 94025
- Owner or operator
- Hello Heart (10095763)
- Roles
- Repackager or relabeler, Specification developer
- First device listed
- April 24, 2026
- Registered through
- 2026
- Brand names listed
- Hello Heart Pill Box, Hello Heart UAM-907HH
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Reminder, Medication | NXQ | 1 | Specification developer | accessdata.fda.gov |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | 2 | Repackager or relabeler | 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 |
|---|---|---|---|---|---|---|
| November 22, 2023 | K232621 | Blood pressure monitor | DXN | Substantially Equivalent | Guangdong Transtek Medical Electronics Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated November 22, 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.