Data / Medical devices / South Korea / InBody Factory #2
InBody Factory #2: FDA-registered device maker in Cheonan-si Chungnam, South Korea, 4 510(k) clearances
InBody Factory #2 is registered with the FDA (registration 3022764531) in Cheonan-si Chungnam, South Korea. It lists 4 device types. The FDA files 4 510(k) clearances under its listings, the newest dated August 2, 2023. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3022764531
- Address
- 330, Yeongok-gil Ipjang-myueon, Seoubuk-gu, Cheonan-si Chungnam, South Korea, 31026
- Owner or operator
- InBody Co. Ltd. (9041413)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- November 8, 2010
- Registered through
- 2027
- Brand names listed
- BP160, BP160B, BP170, BP170B, BPBIO 320 S, BPBIO 320 SN, BPBIO 330 S, BPBIO 330 SN and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Blood Pressure Cuff | DXQ | 2 | Manufacturer | accessdata.fda.gov |
| Platform, Force-Measuring | KHX | 1 | Exporter to the US | accessdata.fda.gov |
| Scale, Patient | FRW | 1 | 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 |
|---|---|---|---|---|---|---|
| August 2, 2023 | K231174 | BPBIO750 | DXN | Substantially Equivalent | Inbody Co., Ltd. | accessdata.fda.gov |
| January 6, 2021 | K200560 | InBody | DXN | Substantially Equivalent | Inbody Co., Ltd. | accessdata.fda.gov |
| December 4, 2020 | K200442 | InBody | DXN | Substantially Equivalent | Inbody Co., Ltd. | accessdata.fda.gov |
| September 4, 2013 | K131064 | BIOSPACE | DXN | Substantially Equivalent | Biospace Corporation Limited | accessdata.fda.gov |
Compare with other makers
- All makers of System, Measurement, Blood-Pressure, Non-Invasive
- All makers of Scale, Patient
- All makers of Platform, Force-Measuring
- All makers of Blood Pressure Cuff
Updated August 2, 2023. 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.