Data / Medical devices / South Korea / SELVAS Healthcare, Inc.
SELVAS Healthcare, Inc.: FDA-registered device maker in Yuseong-gu Daejeon, South Korea, 3 510(k) clearances
SELVAS Healthcare, Inc. is registered with the FDA (registration 9616164) in Yuseong-gu Daejeon, South Korea. It lists 3 device types. The FDA files 3 510(k) clearances under its listings, the newest dated February 18, 2015. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 9616164
- FEI number
- 3001058906
- Address
- 155, Sinseong-ro, Yuseong-gu Daejeon, South Korea, 34109
- Owner or operator
- SELVAS Healthcare, Inc. (9034171)
- Roles
- Manufacturer
- First device listed
- October 11, 2009
- Registered through
- 2027
- Brand names listed
- ACCUNIQ BC300, ACCUNIQ BC310, ACCUNIQ BC360, ACCUNIQ BC380, ACCUNIQ BC390, ACCUNIQ BC720, ACCUNIQ BC730, ACCUNIQ BP210 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Analyzer, Body Composition | MNW | 2 | Manufacturer | accessdata.fda.gov |
| Analyzer, Body Composition, Exempt | PUH | 2 | Manufacturer | accessdata.fda.gov |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | 2 | 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 18, 2015 | K140045 | BODY COMPOSITION ANALYZER | MNW | Substantially Equivalent | Jawon Medical Co., Ltd. | accessdata.fda.gov |
| October 9, 2009 | K092432 | AUTOMOATIC BLOOD PRESSURE MONITOR, MODELS: EASY X 800 AND 900 (R/L) | DXN | Substantially Equivalent | Jawon Medical Co., Ltd. | accessdata.fda.gov |
| October 8, 2009 | K092431 | BODY COMPOSITION ANALYZER, MODEL: IOI 353 | MNW | Substantially Equivalent | Jawon Medical Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Analyzer, Body Composition, Exempt
- All makers of Analyzer, Body Composition
- All makers of System, Measurement, Blood-Pressure, Non-Invasive
Updated February 18, 2015. 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.