Data / Medical devices / China / Dalian Labtek Science & Development Co Ltd
Dalian Labtek Science & Development Co Ltd: FDA-registered device maker in Dalian Liaoning, China, 3 510(k) clearances
Dalian Labtek Science & Development Co Ltd is registered with the FDA (registration 3010148613) in Dalian Liaoning, China. It lists 1 device type. The FDA files 3 510(k) clearances under its listings, the newest dated February 9, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010148613
- Address
- 1-18-17, Liandong Street, Advanced Equipment Manufacturing Industry Park Economic-Technological Development Zone, Dalian Liaoning, China, 116021
- Owner or operator
- Dalian Labtek Science & Development Co Ltd (10042137)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- October 23, 2012
- Registered through
- 2026
- Brand names listed
- A-V Hand&Foot Pump, Model LBTK-M-I 1000, Veinoflow SCD, LBTK-M-I 5006, Veinoflow SCD, Model LBTK-M-I 5001
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Sleeve, Limb, Compressible | JOW | 2 | 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 |
|---|---|---|---|---|---|---|
| February 9, 2022 | K213313 | Veinoflow SCD (Model: LBTK-M-I 5006) | JOW | Substantially Equivalent | Dalian Labtek Science & Development Co., Ltd. | accessdata.fda.gov |
| August 16, 2013 | K123830 | INTERMITTENT PNEUMATIC COMPRESSION DEVICE | JOW | Substantially Equivalent | Dalian Labtek Science & Development Co., Ltd. | accessdata.fda.gov |
| August 17, 2012 | K121718 | A-V FOOT PUMP | JOW | Substantially Equivalent | Dalian Labtek Science & Development Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated February 9, 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.