Jiangxi Royall Smart Technology Co., Ltd.
ChinaFDA applicant, unverified FDA FEI 3026164517
- Devices
- 2
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA FEI
What Jiangxi Royall Smart Technology Co., Ltd. makes
Jiangxi Royall Smart Technology Co., Ltd. manufactures physical therapy transcutaneous neuromuscular electrical stimulation systems, including the Equate device and the TENS & EMS Device models LY-ET-01, LY-ET-02, and LY-ET-04.
The company's devices are classified as Class II and are listed in the FDA 510(k) and FDA UDI registries. Jiangxi Royall Smart Technology Co., Ltd. is based in the US.
Catalogue
- Registry: GUDID
TENS & EMS Device (LY-ET-01, LY-ET-02, LY-ET-04) Ref K230443
Regimes: 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 3026164517
- DUNS number
- 554514493
- Address
- Building 1, 2nd-3rd Floor and Building 3, 2nd Floor, Lefeng Technology Park, Northern Area, Ganzhou Jiangxi
Frequently asked questions
How many devices does Jiangxi Royall Smart Technology Co., Ltd. have in the registry?
The registry currently lists 2 devices for Jiangxi Royall Smart Technology Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Jiangxi Royall Smart Technology Co., Ltd.'s devices?
Among its 2 most recently registered devices, Jiangxi Royall Smart Technology Co., Ltd. has devices listed in FDA 510(k) (1 device) and FDA GUDID (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Jiangxi Royall Smart Technology Co., Ltd.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Jiangxi Royall Smart Technology Co., Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Jiangxi Royall Smart Technology Co., Ltd. in the registry?
The most recently registered devices listed for Jiangxi Royall Smart Technology Co., Ltd. include Equate LY-ET-01 and TENS & EMS Device (LY-ET-01, LY-ET-02, LY-ET-04).