K210572 is an FDA 510(k) clearance for the Neurodyn V2.0, Neurodyn Aussie V2.0. This device is classified as a Stimulator, Muscle, Powered (Class II - Special Controls, product code IPF).
Submitted by Ibramed Equipamentos Medicos (Amparo, BR). The FDA issued a Cleared decision on May 11, 2021, 74 days after receiving the submission on February 26, 2021.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5850.
| 510(k) Number | K210572 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 26, 2021 |
| Decision Date | May 11, 2021 |
| Days to Decision | 74 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 |