Data / Medical devices / United States / Vave Health Inc
Vave Health Inc: FDA-registered device maker in San Jose, CA, United States, 2 510(k) clearances
Vave Health Inc is registered with the FDA (registration 3016854601) in San Jose, CA, United States. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated August 30, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3016854601
- Address
- 3031 Tisch Way 110 Plaza West, San Jose, CA, United States, 95128
- Owner or operator
- Vave Health (10073325)
- Roles
- Manufacturer, Specification developer
- First device listed
- May 8, 2020
- Registered through
- 2026
- Brand names listed
- Vave Personal Ultrasound System, Vave Phased, Vave Universal Wireless Ultrasound device, Vave Wireless Ultrasound System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Imaging, Pulsed Doppler, Ultrasonic | IYN | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Transducer, Ultrasonic, Diagnostic | ITX | 2 | Manufacturer, 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 |
|---|---|---|---|---|---|---|
| August 30, 2024 | K241051 | Vave Wireless Ultrasound System | IYN | Substantially Equivalent | Vave Health, Inc. | accessdata.fda.gov |
| July 10, 2019 | K191541 | Vave Personal Ultrasound System | IYO | Substantially Equivalent | Vave Health, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Transducer, Ultrasonic, Diagnostic
- All makers of System, Imaging, Pulsed Echo, Ultrasonic
- All makers of System, Imaging, Pulsed Doppler, Ultrasonic
Updated August 30, 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.