Data / Medical devices / Taiwan / Astek Technology Ltd.
Astek Technology Ltd.: FDA-registered device maker in Tainan, Taiwan, 1 510(k) clearance
Astek Technology Ltd. is registered with the FDA (registration 3013077196) in Tainan, Taiwan. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated January 11, 2020. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3013077196
- Address
- No.118, Taizih Rd. Rende Hsiang, Tainan Hsien, Tainan, Taiwan, 717
- Owner or operator
- ASTEK Technology Ltd. (10061317)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- October 7, 2019
- Registered through
- 2027
- Brand names listed
- AK100B;AK100C;AK100D;AK101;AK101B;AK101C;AK101D;AK350AIFT;EPB047047;EPB047098;EPD090147;EPD105203;EPG046046;, AK360;AK368;AK370;AK660;AK770;AK880;AK10MA;AK325A;AK320A;AK350A;AK500;AK510;AK520;KR1300;KR1600;AK100;, EPG050050;EPG053083;EPL050050;EPL073150;EPP050050;EPP118058;EPP048000, TENS Stimulator AK-10M, TENS and EMS Stimulator AK3-20, TENS and EMS Stimulator AK3-25, TENS and EMS Stimulator AK3-50
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Massager, Therapeutic, Electric | ISA | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Stimulator, Muscle, Powered | IPF | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Stimulator, Nerve, Transcutaneous, For Pain Relief | GZJ | 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 |
|---|---|---|---|---|---|---|
| January 11, 2020 | K183074 | TENS and EMS Stimulator, TENS Stimulator | IPF | Substantially Equivalent | Astek Technology , Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Stimulator, Nerve, Transcutaneous, For Pain Relief
- All makers of Stimulator, Muscle, Powered
- All makers of Massager, Therapeutic, Electric
Updated January 11, 2020. 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.