Data / Medical devices / United States / Wellvii Inc
Wellvii Inc: FDA-registered device maker in Palm Beach Gardens, FL, United States, 2 510(k) clearances
Wellvii Inc is registered with the FDA (registration 3037007069) in Palm Beach Gardens, FL, United States. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated February 2, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3037007069
- Address
- 4521 Pga Blvd Pmb 341, Palm Beach Gardens, FL, United States, 33418
- Owner or operator
- Wellvii Inc (10047727)
- Roles
- Specification developer
- First device listed
- June 19, 2017
- Registered through
- 2026
- Brand names listed
- InstaTemp, Wellvii Temp, VitalDetect
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Continuous Measurement Thermometer | FLL | 2 | Specification developer | accessdata.fda.gov |
| Oximeter | DQA | 2 | Specification developer | accessdata.fda.gov |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | 2 | Specification developer | 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 2, 2024 | K231625 | VitalDetect | FLL | Substantially Equivalent | Wellvii, Inc. | accessdata.fda.gov |
| July 20, 2016 | K152905 | ARC InstaTemp Non-Touch Thermometer, ARC InstaTemp MD Non-Touch Thermometer | FLL | Substantially Equivalent | Arc Devices Limited | accessdata.fda.gov |
Compare with other makers
- All makers of Continuous Measurement Thermometer
- All makers of System, Measurement, Blood-Pressure, Non-Invasive
- All makers of Oximeter
Updated February 2, 2024. 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.