Data / Medical devices / China / Shenzhen Shufang Electronic Commerce Co., Ltd.
Shenzhen Shufang Electronic Commerce Co., Ltd.: FDA-registered device maker in Shenzhen Guangdong, China, 1 510(k) clearance
Shenzhen Shufang Electronic Commerce Co., Ltd. is registered with the FDA (registration 3017150671) in Shenzhen Guangdong, China. It lists 6 device types. The FDA files 1 510(k) clearance under its listings, the newest dated December 8, 2022. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3017150671
- Address
- 3212, Baoshanshidai Building, Minqiang Community, Minzhi Street, Longhua District, Shenzhen, Shenzhen Guangdong, China, 518110
- Owner or operator
- Shenzhen Shufang Electronic Commerce Co., Ltd. (10086976)
- Roles
- Exporter to the US, Foreign private label distributor, Manufacturer, Specification developer
- First device listed
- December 28, 2022
- Registered through
- 2027
- Brand names listed
- Irrigator , Powered Nasal, Lamp, Infrared, Therapeutic Heating-OPOVE- R1,R2,R3., Massager, Therapeutic, Electric-OPOVE-M3 PRO2;Apex;M3pro;M3;M3 mini;M3Go;M5; Mebak-3;5;M1;Chic;mini;Entesi 3, Mebak Leg Compression Massagers LM01, Unit, Oral Irrigation ORALNEED
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Irrigator, Powered Nasal | KMA | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Lamp, Infrared, Therapeutic Heating | ILY | 2 | Specification developer | accessdata.fda.gov |
| Massager, Powered Inflatable Tube | IRP | 2 | Exporter to the US, Foreign private label distributor | accessdata.fda.gov |
| Massager, Therapeutic, Electric | ISA | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Pack, Hot Or Cold, Water Circulating | ILO | 2 | Manufacturer, Specification developer | 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 |
|---|---|---|---|---|---|---|
| December 8, 2022 | K221862 | YY-A02-B Overlapped Compression Therapy | IRP | Substantially Equivalent | Huizhou Xinyi Technology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Lamp, Infrared, Therapeutic Heating
- All makers of Unit, Oral Irrigation
- All makers of Massager, Powered Inflatable Tube
- All makers of Irrigator, Powered Nasal
- All makers of Massager, Therapeutic, Electric
- All makers of Pack, Hot Or Cold, Water Circulating
Updated December 8, 2022. 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.