Data / Medical devices / China / Xiamen Emoka Health Science And Technology Company Limited
Xiamen Emoka Health Science And Technology Company Limited: FDA-registered device maker in Xiamen Fujian, China, 1 510(k) clearance
Xiamen Emoka Health Science And Technology Company Limited is registered with the FDA (registration 3012184077) in Xiamen Fujian, China. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated March 15, 2023. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3012184077
- Address
- No. 577 Tongfu Road Tong'an District, Xiamen Fujian, China, 361100
- Owner or operator
- Xiamen Emoka Health Science and Technology Company Limited (10050528)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- November 30, 2015
- Registered through
- 2026
- Brand names listed
- 3D Massage Pillow (Model: EMK-134A), Air Compression Leg Massager, model: EMK-701, EP24392US, EMK-701C, EMK-701AE, EMK-712, EMK-702, EMK-703B, EMK-707, EMK-707B, EMK-700, RF-ALM072, RF-ALM072-H, RP-ALM071C, RP-ALM075, SHI-55, SHI-66, SHI-77, EMK-723/KH353 Warming Compression Knee or Calf Massager, Foot massager, Handheld massager, Lady bettles massager, Leg Massager and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Massager, Powered Inflatable Tube | IRP | 2 | Manufacturer | accessdata.fda.gov |
| Massager, Therapeutic, Electric | ISA | 1 | 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 |
|---|---|---|---|---|---|---|
| March 15, 2023 | K222991 | Air Compression Leg Massager (model: EMK-701) | IRP | Substantially Equivalent | Xiamen Emoka Health Science & Technology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated March 15, 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.