Actherm, Inc.
TaiwanFDA applicant, unverified
- Devices
- 8
What Actherm, Inc. makes
Actherm, Inc. manufactures digital clinical thermometers, including oral, rectal, and ear-based models with rapid-reading capabilities (10 seconds or less). Their product line includes infrared ear thermometers with disposable probe covers, lightweight probe thermometers for basal and hypothermia monitoring, and reusable probe covers for clinical use. Some models feature left-right handed probes and are designed for versatile medical applications.
The company’s devices are classified as Class II under FDA regulations and are listed in the FDA’s 510(k) premarket notification database. These products are intended for use in clinical settings in the United States, where regulatory compliance is required for medical devices.
Catalogue
Actherm Digital Clinical Thermometer, Models ACT2000, ACT2010, ACT2000+, ACT2010+, ACT2020+ Ref K010238
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Digital Clinical Thermometer, Models ACT2130, Act 2230, Act 2330, Act 3136, And Act 3030 Ref K031905
Regimes: 510(k) Registry: 510(k)Actherm Digital Clinical Thermometer Probe Covers, Model(S) MEDACCU1010, MEDACCU1010-1, MEDACCU1020 Ref K083419
Regimes: 510(k) Registry: 510(k)Digital Clinical Thermometer, Model Act 3020 Ref K021614
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Actherm, Inc. have in the registry?
The registry currently lists 8 devices for Actherm, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Actherm, Inc.'s devices?
Among its 8 most recently registered devices, Actherm, Inc. has devices listed in FDA 510(k) (8 devices).
What risk classes do Actherm, Inc.'s devices fall under?
Among its 8 most recently registered devices, the classes recorded for Actherm, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Actherm, Inc. in the registry?
The most recently registered devices listed for Actherm, Inc. include ACTHERM DIGITAL CLINICAL THERMOMETER, MODELS ACT2000, ACT2010, ACT2000+, ACT2010+, ACT2020+, ACTHERM INFRARED EAR THERMOMETER ACT 8000R SERIES AND ITS PROBE COVER MED ACCU2010, CLASSIC/HYPOTHERMIA, FLEXIBLE, 10-SECOND, LEFT-RIGHT HANDED, BASAL, LIGHTWEIGHT-PROBE DIGITAL CLINICAL THERMOMETER and DIGITAL CLINICAL THERMOMETER, MODELS ACT2130, ACT 2230, ACT 2330, ACT 3136, AND ACT 3030.