Data / Medical devices / China / Jiangxi Royall Smart Technology Co., Ltd.
Jiangxi Royall Smart Technology Co., Ltd.: FDA-registered device maker in Ganzhou Jiangxi, China, 1 510(k) clearance
Jiangxi Royall Smart Technology Co., Ltd. is registered with the FDA (registration 3026164517) in Ganzhou Jiangxi, China. It lists 5 device types. The FDA files 1 510(k) clearance under its listings, the newest dated May 22, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3026164517
- Address
- Building 1, 2nd-3rd Floor and Building 3, 2nd Floor, Lefeng Technology Park, Northern Area Huangbu Industrial Park, Shangyou County, Ganzhou Jiangxi, China, 341200
- Owner or operator
- Jiangxi Royall Smart Technology Co., Ltd. (10086681)
- Roles
- Manufacturer
- First device listed
- December 1, 2022
- Registered through
- 2026
- Brand names listed
- Oral Irrigator (Model: C2, C5, C6), Sonic Electric Toothbrush (model: YM3(W)), Sonic Electric Toothbrush (model: YM3), Sonic Electric Toothbrush (model: YM502(W), YM502(B), YM502(E), TBM10T, TBM11T, LY-T01), Sonic Electric Toothbrush (model: YM6(W), YM6(B), YM6(E), YM6Pro(W), YM6Pro(B), YM6Pro(E)), TENS & EMS Device (Model: LY-ET-01, LY-ET-02, LY-ET-04), Water flosser (model: CL1, CL2, CL1(W), CL2(W))
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Stimulator, Electrical, Transcutaneous, For Arthritis | NYN | 2 | Manufacturer | accessdata.fda.gov |
| Stimulator, Muscle, Powered, For Muscle Conditioning | NGX | 2 | Manufacturer | accessdata.fda.gov |
| Stimulator, Nerve, Transcutaneous, Over-The-Counter | NUH | 2 | Manufacturer | accessdata.fda.gov |
| Toothbrush, Powered | JEQ | 1 | Manufacturer | accessdata.fda.gov |
| Unit, Oral Irrigation | EFS | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 22, 2023 | K230443 | TENS & EMS Device (LY-ET-01, LY-ET-02, LY-ET-04) | NUH | Substantially Equivalent | Jiangxi Royall Smart Technology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Toothbrush, Powered
- All makers of Stimulator, Muscle, Powered, For Muscle Conditioning
- All makers of Stimulator, Nerve, Transcutaneous, Over-The-Counter
- All makers of Stimulator, Electrical, Transcutaneous, For Arthritis
- All makers of Unit, Oral Irrigation
Updated May 22, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.