Data / Medical devices / South Korea / InBody Co, Ltd.
InBody Co, Ltd.: FDA-registered device maker in Cheonan-si Chungnam, South Korea, 7 510(k) clearances
InBody Co, Ltd. is registered with the FDA (registration 3003074886) in Cheonan-si Chungnam, South Korea. It lists 15 device types. The FDA files 7 510(k) clearances under its listings, the newest dated January 6, 2021. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3003074886
- Address
- 15, Heugam-gil, Ipjang-myueon, Seoubuk-gu, Cheonan-si Chungnam, South Korea, 31025
- Owner or operator
- InBody Co. Ltd. (9041413)
- Roles
- Manufacturer
- First device listed
- August 31, 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 |
|---|---|---|---|---|
| Analyzer, Body Composition | MNW | 2 | Manufacturer | accessdata.fda.gov |
| Analyzer, Body Composition, Exempt | PUH | 2 | Manufacturer | accessdata.fda.gov |
| Ataxiagraph | GWW | 1 | Manufacturer | accessdata.fda.gov |
| Blood Pressure Cuff | DXQ | 2 | Manufacturer | accessdata.fda.gov |
| Disinfectant, Medical Devices | LRJ | 1 | Manufacturer | accessdata.fda.gov |
| Dynamometer, Ac-Powered | LBB | 2 | Manufacturer | accessdata.fda.gov |
| Electrode, Electrocardiograph | DRX | 2 | Manufacturer | accessdata.fda.gov |
| Exerciser, Measuring | ISD | 2 | Manufacturer | accessdata.fda.gov |
| Medical Device Data System | OUG | 1 | Manufacturer | accessdata.fda.gov |
| Non-Surgical Gown | OEA | 1 | Manufacturer | accessdata.fda.gov |
| Platform, Force-Measuring | KHX | 1 | Manufacturer | accessdata.fda.gov |
| Scale, Patient | FRW | 1 | Manufacturer | accessdata.fda.gov |
| Scale, Stand-On, Patient | FRI | 1 | Manufacturer | accessdata.fda.gov |
| System, Isokinetic Testing And Evaluation | IKK | 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 |
|---|---|---|---|---|---|---|
| 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 23, 2014 | K141483 | BIOSPACE BODY COMPOSITION ANALYZER | MNW | Substantially Equivalent | Biospace Corporation Limited | accessdata.fda.gov |
| November 25, 2013 | K130777 | INBODY | MNW | Substantially Equivalent | Biospace Corporation Limited | accessdata.fda.gov |
| September 4, 2013 | K131064 | BIOSPACE | DXN | Substantially Equivalent | Biospace Corporation Limited | accessdata.fda.gov |
| March 8, 2013 | K123228 | INBODY 770, INBODY 570, INBODY S10, INBODY H20/INBODY H20(B) | MNW | Substantially Equivalent | Biospace Corporation Limited | accessdata.fda.gov |
| March 10, 2010 | K092786 | INBODY, MODELS: 270, R20, R20B | MNW | Substantially Equivalent | Biospace Corporation Limited | accessdata.fda.gov |
Compare with other makers
- All makers of Analyzer, Body Composition
- All makers of Scale, Patient
- All makers of Electrode, Electrocardiograph
- All makers of Dynamometer, Ac-Powered
- All makers of System, Measurement, Blood-Pressure, Non-Invasive
- All makers of Analyzer, Body Composition, Exempt
Updated January 6, 2021. 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.