Data / Medical devices / Taiwan / Leltek Inc.
Leltek Inc.: FDA-registered device maker in New Taipei City, Taiwan, 2 510(k) clearances
Leltek Inc. is registered with the FDA (registration 3014555455) in New Taipei City, Taiwan. It lists 4 device types. The FDA files 2 510(k) clearances under its listings, the newest dated May 8, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014555455
- Address
- 6F.-3, No. 293, Sec. 1, Beixin Rd., Xindian Dist., New Taipei City, Taiwan, 23147
- Owner or operator
- LELTEK (10074230)
- Roles
- Contract manufacturer, Manufacturer, Repackager or relabeler
- First device listed
- September 19, 2024
- Registered through
- 2026
- Brand names listed
- Computer Cart, Endoscopy Cart, Fixed and Variable Height Roll Cart, Roll Stand, Healium Intelliscan LX192LC, Patient Monitor Roll Stand, INFUSION Roll Stand, ECG Trolley, Pad Roll Stand, Medical Trolley, Display Trolley, Patient Monitor Wall Mount, Wall Mount, Display Mount, Ventilator Arm, ECG Arm, Pivot Arm,Variable Height Mount, SuperSonic PocketVu and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Stand, Infusion | FOX | 1 | Repackager or relabeler | accessdata.fda.gov |
| System, Imaging, Pulsed Doppler, Ultrasonic | IYN | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Transducer, Ultrasonic, Diagnostic | ITX | 2 | Contract manufacturer, 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 |
|---|---|---|---|---|---|---|
| May 8, 2025 | K243226 | Ultrasound Imaging System (LU700 Series); Ultrasound Imaging System (128 Series); Ultrasound Imaging System (LX Series) | IYN | Substantially Equivalent | Leltek, Inc. | accessdata.fda.gov |
| September 11, 2024 | K241161 | Ultrasound Imaging System (LK128L); Ultrasound Imaging System (LK128LH); Ultrasound Imaging System (LK128C); Ultrasound Imaging System (LK128M); Ultrasound Imaging System (LK128PA); Ultrasound Imaging System (LK128E); Ultrasound Imaging System (LU700C); Ultrasound Imaging System (LU700L); Ultrasound Imaging System (LU710L); Ultrasound Imaging System (LU710LH); Ultrasound Imaging System (LU710C); Ultrasound Imaging System (LU710M); Ultrasound Imaging System (LU710PA); Ultrasound Imaging | IYN | Substantially Equivalent | Leltek, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Transducer, Ultrasonic, Diagnostic
- All makers of System, Imaging, Pulsed Echo, Ultrasonic
- All makers of System, Imaging, Pulsed Doppler, Ultrasonic
- All makers of Stand, Infusion
Updated May 8, 2025. 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.