Data / Medical devices / South Korea / Feel Tech Bio Co., Ltd.
Feel Tech Bio Co., Ltd.: FDA-registered device maker in Dongnam-gu, Cheonan-si Chungnam, South Korea, 6 510(k) clearances
Feel Tech Bio Co., Ltd. is registered with the FDA (registration 3006380458) in Dongnam-gu, Cheonan-si Chungnam, South Korea. It lists 2 device types. The FDA files 6 510(k) clearances under its listings, the newest dated December 23, 2011. Registered through 2027. FDA data exported November 3, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3006380458
- Address
- 1079-20, Charyeonggogae-ro GWANGDEOK-MYEON, Dongnam-gu, Cheonan-si Chungnam, South Korea, 31223
- Owner or operator
- Feel Tech Bio Co., Ltd. (9099910)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- July 10, 2007
- Registered through
- 2027
- Brand names listed
- ELASTY FINE SYRINGE, Easy Touch, Easy Touch Insulin Syringe, FMS (Fine Micro Syringe), FPN-001, FPN-002, FPN-003, FPN-004 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Needle, Hypodermic, Single Lumen | FMI | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Syringe, Piston | FMF | 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 |
|---|---|---|---|---|---|---|
| December 23, 2011 | K112789 | EASY TOUCH | FMI | Substantially Equivalent | Mhc Medical Products, LLC | accessdata.fda.gov |
| September 2, 2010 | K102178 | EASY TOUCH | FMF | Substantially Equivalent | Mhc Medical Products | accessdata.fda.gov |
| January 14, 2010 | K092831 | DISPOSABLE HYPODERMIC NEEDLE | FMI | Substantially Equivalent | Feel Tech | accessdata.fda.gov |
| July 9, 2009 | K091474 | EASY.TOUCH INSULIN SYRINGE | FMF | Substantially Equivalent | Masters Healthcare, LLC | accessdata.fda.gov |
| June 4, 2008 | K080904 | FEEL-FINE INSULIN PEN NEEDLE | FMI | Substantially Equivalent | Feel Tech | accessdata.fda.gov |
| June 20, 2007 | K070917 | FEEL-JECT INSULIN SYRINGE | FMF | Substantially Equivalent | Feel Tech | accessdata.fda.gov |
Compare with other makers
Updated December 23, 2011. 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.