Data / Medical devices / China / Shaoxing DL Healthcare Co., Ltd.
Shaoxing DL Healthcare Co., Ltd.: FDA-registered device maker in Shaoxing Zhejiang, China, 1 510(k) clearance
Shaoxing DL Healthcare Co., Ltd. is registered with the FDA (registration 3014659326) in Shaoxing Zhejiang, China. It lists 5 device types. The FDA files 1 510(k) clearance under its listings, the newest dated January 17, 2019. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3014659326
- Address
- No. 68, Majia Road, Ludong industrial district, Baiguan Street, Shangyu District, Shaoxing Zhejiang, China, 312300
- Owner or operator
- Shaoxing DL Healthcare Co., Ltd. (10058670)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- January 22, 2019
- Registered through
- 2026
- Brand names listed
- Adhesive Electrode, MASSAGE GUN, MG-8000, Medical Face-shield, Medical goggles, DLYZ-01, DLYZ-02, Syrtenty Electrode Pads, CSYR-S3177-20, Syrtenty Electrode Pads, TSYR-S2020-16, Syrtenty Electrode Pads, TSYR-S2040-12, Syrtenty Electrode Pads, TSYR-S4560-2 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessory, Surgical Apparel | LYU | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Cable, Electrode | IKD | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Electrode, Cutaneous | GXY | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Massager, Therapeutic, Electric | ISA | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| QLA | QLA | Exporter to the US, 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 |
|---|---|---|---|---|---|---|
| January 17, 2019 | K182111 | DL Self-adhesive Electrode | GXY | Substantially Equivalent | Shaoxing DL Healthcare Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Electrode, Cutaneous
- All makers of Cable, Electrode
- All makers of Massager, Therapeutic, Electric
- All makers of Accessory, Surgical Apparel
Updated January 17, 2019. 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.