Data / Medical devices / South Korea / Feeltech Co.,ltd.
Feeltech Co.,ltd.: FDA-registered device maker in Gunsan-si Jeonbuk, South Korea, 5 510(k) clearances
Feeltech Co.,ltd. is registered with the FDA (registration 3010462274) in Gunsan-si Jeonbuk, South Korea. It lists 5 device types. The FDA files 5 510(k) clearances under its listings, the newest dated October 20, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010462274
- Address
- 4 Floor, Standard Factory 5-dong, part of 1 Floor, Standard Factory 1-dong, part of 3, 4 Floor Standard Factory 2-dong,15, Jayumuyeok 2-gil, Gunsan-si Jeonbuk, South Korea, 54001
- Owner or operator
- Feeltech Co.,Ltd. (10050336)
- Roles
- Complaint file establishment, Contract manufacturer, Exporter to the US, Manufacturer
- First device listed
- November 4, 2015
- Registered through
- 2026
- Brand names listed
- AI 1.8 NEEDLE, AMI, ELASTY Meso Needle, ELASTY Micro Cannula, Elasty, FEELject LDV(Low dead volume) Syringe, FEELject NEEDLES, Feel Soft Micro Needles and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Low Dead Space Piston Syringe | QNQ | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Needle, Acupuncture, Single Use | MQX | 2 | Manufacturer | accessdata.fda.gov |
| Needle, Hypodermic, Single Lumen | FMI | 2 | Complaint file establishment, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Suture, Surgical, Absorbable, Polydioxanone | NEW | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Syringe, Piston | FMF | 2 | Contract 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 |
|---|---|---|---|---|---|---|
| October 20, 2025 | K251414 | Miracu Polydioxanone (PDO) Suture and Needle (MONO) | NEW | Substantially Equivalent | Feeltech Co., Ltd. | accessdata.fda.gov |
| October 15, 2025 | K250107 | V-soft Line Barbed Surgical Suture (Various) | NEW | Substantially Equivalent | Feeltech Co., Ltd. | accessdata.fda.gov |
| May 31, 2023 | K213010 | FEELject LDV (Low dead volume) syringe | QNQ | Substantially Equivalent | Feeltech Co., Ltd. | accessdata.fda.gov |
| November 14, 2018 | K172602 | Miracu | NEW | Substantially Equivalent | Feeltech Co., Ltd. | accessdata.fda.gov |
| January 14, 2010 | K092831 | DISPOSABLE HYPODERMIC NEEDLE | FMI | Substantially Equivalent | Feel Tech | accessdata.fda.gov |
Compare with other makers
- All makers of Needle, Acupuncture, Single Use
- All makers of Needle, Hypodermic, Single Lumen
- All makers of Suture, Surgical, Absorbable, Polydioxanone
- All makers of Syringe, Piston
- All makers of Low Dead Space Piston Syringe
Updated October 20, 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.