The following data is part of a premarket notification filed by Ncs Lab Srl with the FDA for Shoulder Pacemakertm.
| Device ID | K220994 |
| 510k Number | K220994 |
| Device Name: | Shoulder PacemakerTM |
| Classification | Stimulator, Muscle, Powered |
| Applicant | NCS Lab Srl Via Pola Esterna 4/12 Carpi, MO 41012 |
| Contact | Matteo Mantovani |
| Correspondent | Tim Marjenin MCRA, LLC 803 7th St. NW Washington, DC 20001 |
| Product Code | IPF |
| Subsequent Product Code | HCC |
| Subsequent Product Code | KQX |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-04-04 |
| Decision Date | 2022-10-14 |