Scale-Tronix, Inc.
United StatesFDA applicant, unverified
- Devices
- 4
What Scale-Tronix, Inc. makes
Scale-Tronix, Inc. manufactures precision medical scales designed for neonatal care, including incubator scales (Model 4050 and modified variants), platform scales for clinical use, and infant scales for incubators and warmers. These devices are engineered to measure weight accurately in critical care environments where patient monitoring is essential.
The company’s products are regulated under the FDA’s 510(k) pathway, with devices classified as Class I and Class II. They are listed in the FDA’s 510(k) clearance registry, reflecting compliance with US medical device regulations. The manufacturer is based in the United States.
Catalogue
Scale-Tronix Incubator Scale MODEL:4050/Modified Ref K904286
Regimes: 510(k) Registry: 510(k)Scale-Tronix Incubator Scale MODEL:4050 Ref K902260
Regimes: 510(k) Registry: 510(k)Scale-Tronix Platform Scale Ref K912662
Regimes: 510(k) Registry: 510(k)4002 Infant Scale For Incubators And Warmers Ref K935609
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Scale-Tronix, Inc. have in the registry?
The registry currently lists 4 devices for Scale-Tronix, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Scale-Tronix, Inc.'s devices?
Among its 4 most recently registered devices, Scale-Tronix, Inc. has devices listed in FDA 510(k) (4 devices).
What risk classes do Scale-Tronix, Inc.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Scale-Tronix, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Scale-Tronix, Inc. in the registry?
The most recently registered devices listed for Scale-Tronix, Inc. include SCALE-TRONIX INCUBATOR SCALE MODEL:4050/MODIFIED, SCALE-TRONIX INCUBATOR SCALE MODEL:4050, SCALE-TRONIX PLATFORM SCALE and 4002 INFANT SCALE FOR INCUBATORS AND WARMERS.