Mgnewton, Ltd.
South KoreaFDA applicant, unverified FDA
- Devices
- 3
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA establishment
What Mgnewton, Ltd. makes
Mgnewton, Ltd. manufactures electrotherapy devices, including the ELEC Master and ELEC Master Dual for muscle stimulation, as well as the CURA-Temp for temperature-controlled therapy applications.
These products are regulated under FDA Class I and Class II classifications, with authorisation records maintained in the FDA’s 510(k) database. The company is based in the United States.
Catalogue
- Registry: GUDID
ELEC Master, ELEC Master Dual Ref K202963
Regimes: 510(k) Registry: 510(k)CURA-Temp Ref K202965
Regimes: 510(k) Registry: 510(k)
FDA establishments
- Mgnewton Ltd. Gyengsan-si Gyeongbuk · KR FEI 3015396763
Frequently asked questions
How many devices does Mgnewton, Ltd. have in the registry?
The registry currently lists 3 devices for Mgnewton, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Mgnewton, Ltd.'s devices?
Among its 3 most recently registered devices, Mgnewton, Ltd. 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 Mgnewton, Ltd.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Mgnewton, Ltd.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Mgnewton, Ltd. in the registry?
The most recently registered devices listed for Mgnewton, Ltd. include ELEC Master Dual, ELEC Master, ELEC Master Dual and CURA-Temp.
Which FDA establishments are linked to Mgnewton, Ltd.?
1 FDA establishment is linked to Mgnewton, Ltd. in the registry; they are listed on the company page.