Healthcheck Corp.
United StatesFDA applicant, unverified
- Devices
- 9
What Healthcheck Corp. makes
Healthcheck Corp. manufactures home-use blood pressure monitors, including digital models with automatic inflation and cuff-based readings, as well as pregnancy test kits for at-home use. Their product line also includes digital thermometers and disposable thermostrip devices for temperature measurement.
The company’s devices are regulated under FDA Class I and Class II classifications, with several authorised via the 510(k) pathway. Products are listed in the FDA’s 510(k) registry, and the manufacturer operates from the United States.
Catalogue
Tenstar Ref K874818
Regimes: 510(k) Registry: 510(k)Healthcheck Auto Inflate Digital Bp Monitor Bp-2 Ref K850070
Regimes: 510(k) Registry: 510(k)Digital Blood Pressure Monitor Model Cx-1 Ref K881003
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Ptk Plus. Home Pregnancy Test Ref K861946
Regimes: 510(k) Registry: 510(k)C&T Pregnancy Test Kit Ref K884489
Regimes: 510(k) Registry: 510(k)Ptk Healthcheck Pregnancy Test Kit Ref K844281
Regimes: 510(k) Registry: 510(k)Healthcheck Therm-Strip Ref K863181
Regimes: 510(k) Registry: 510(k)Healthcheck Digital Thermometer Model 1 Th-2 Ref K851379
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Healthcheck Corp. have in the registry?
The registry currently lists 9 devices for Healthcheck Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Healthcheck Corp.'s devices?
Among its 9 most recently registered devices, Healthcheck Corp. has devices listed in FDA 510(k) (9 devices).
What risk classes do Healthcheck Corp.'s devices fall under?
Among its 9 most recently registered devices, the classes recorded for Healthcheck Corp.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Healthcheck Corp. in the registry?
The most recently registered devices listed for Healthcheck Corp. include TENSTAR, HEALTHCHECK AUTO INFLATE DIGITAL BP MONITOR BP-2, DIGITAL BLOOD PRESSURE MONITOR MODEL CX-1 and PULSONIC DIGITAL BLOOD PRESSURE MONITOR MODEL BP-3.