K210674 is an FDA 510(k) clearance for the Shoulder Pacemaker. This device is classified as a Stimulator, Muscle, Powered (Class II - Special Controls, product code IPF).
Submitted by Ncs Lab Srl (Carpi, IT). The FDA issued a Cleared decision on August 24, 2021, 172 days after receiving the submission on March 5, 2021.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5850.
| 510(k) Number | K210674 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 05, 2021 |
| Decision Date | August 24, 2021 |
| Days to Decision | 172 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 |