The following data is part of a premarket notification filed by Inbody Co. Ltd. with the FDA for Inbody.
| Device ID | K200442 |
| 510k Number | K200442 |
| Device Name: | InBody |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | InBody Co. Ltd. InBody Bldg., 625. Eonju-ro, Gangnam-gu Seoul, KR 06106 |
| Contact | Koeun Jung |
| Correspondent | Daniel Kamm Kamm & Associates 8870 Ravello Ct Naples, FL 34114 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-02-24 |
| Decision Date | 2020-12-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08809209590808 | K200442 | 000 |
| 08809209590693 | K200442 | 000 |
| 08809209590563 | K200442 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() INBODY 86918373 5546337 Live/Registered |
InBody Co., Ltd. 2016-02-24 |
![]() INBODY 85447575 4160606 Live/Registered |
INBODY CO., LTD. 2011-10-14 |
![]() INBODY 76165230 2815341 Dead/Cancelled |
BIOSPACE CO., LTD. 2000-11-13 |