Easywell Biomedicals, Inc.
TaiwanFDA applicant, unverified
- Devices
- 3
What Easywell Biomedicals, Inc. makes
Easywell Biomedicals, Inc. manufactures infrared non-contact thermometers, including the Model ACT8100, and transcutaneous electrical nerve stimulation (TENS) systems with optional heating, such as the EASYWELL TENS System.
These devices are classified as Class II under FDA regulations and are supported by 510(k) clearances. The company is based in the United States.
Catalogue
- Registry: GUDID
Infrared Non-contact Thermometer, Model ACT8100 Ref K162509
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Company details
- DUNS number
- 658097795
Frequently asked questions
How many devices does Easywell Biomedicals, Inc. have in the registry?
The registry currently lists 3 devices for Easywell Biomedicals, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Easywell Biomedicals, Inc.'s devices?
Among its 3 most recently registered devices, Easywell Biomedicals, Inc. has devices listed in FDA 510(k) (2 devices) and FDA GUDID (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Easywell Biomedicals, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Easywell Biomedicals, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Easywell Biomedicals, Inc. in the registry?
The most recently registered devices listed for Easywell Biomedicals, Inc. include Pelimex ACT2230Express Dual, Infrared Non-contact Thermometer, Model ACT8100 and EASYWELL TENS System TENS and Heat, EASYWELL TENS System TENS only.