The following data is part of a premarket notification filed by Egzotech Sp. Z O. O. with the FDA for Stella Bio.
| Device ID | K210002 |
| 510k Number | K210002 |
| Device Name: | STELLA BIO |
| Classification | Stimulator, Muscle, Powered |
| Applicant | EGZOTech Sp. Z O. O. Romualda Traugutta 6H Gliwice, PL 44-100 |
| Contact | Michal Mikulski |
| Correspondent | Vaibhav Arvind Rajal mdi Consultants, Inc. 55 Northern Blvd., Suite 200 Great Neck, NY 11021 |
| Product Code | IPF |
| Subsequent Product Code | GZI |
| Subsequent Product Code | GZJ |
| Subsequent Product Code | HCC |
| Subsequent Product Code | KPI |
| Subsequent Product Code | NGX |
| Subsequent Product Code | NUH |
| Subsequent Product Code | NYN |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-01-04 |
| Decision Date | 2021-10-01 |