Data / Medical devices / United Kingdom / viO HealthTech Limited
viO HealthTech Limited: FDA-registered device maker in Camberley Surrey, United Kingdom, 1 510(k) clearance
viO HealthTech Limited is registered with the FDA (registration 3006799946) in Camberley Surrey, United Kingdom. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated August 6, 2013. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3006799946
- Address
- Unit 211, Basepoint Business Centre London Road, Camberley Surrey, United Kingdom, GU15 3HL
- Owner or operator
- viO HealthTech Limited (10023236)
- Roles
- Specification developer
- First device listed
- October 28, 2013
- Registered through
- 2026
- Brand names listed
- OvuSense, OvuSense Fertility Monitor, OvuSense Fertility Monitor System. M026 OvuCore Vaginal Sensor, M426 OvuFirst Skin Worn Sensor and M032 OvuSense App.
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Device, Fertility Diagnostic, Proceptive | LHD | U | 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 6, 2013 | K122337 | OVUSENSE | LHD | Substantially Equivalent | Fertility Focus, Ltd. | accessdata.fda.gov |
Compare with other makers
Updated August 6, 2013. 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.