K210002 is an FDA 510(k) clearance for the STELLA BIO. This device is classified as a Stimulator, Muscle, Powered (Class II - Special Controls, product code IPF).
Submitted by Egzotech Sp. Z O. O. (Gliwice, PL). The FDA issued a Cleared decision on October 1, 2021, 270 days after receiving the submission on January 4, 2021.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5850.
| 510(k) Number | K210002 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 04, 2021 |
| Decision Date | October 01, 2021 |
| Days to Decision | 270 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
| Product Code | IPF - Stimulator, Muscle, Powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.5850 |