Clearance Summary
Shoulder PacemakerTM received FDA 510(k) clearance under submission number K220994, sponsored by Ncs Lab Srl. The device was reviewed via the Traditional premarket notification pathway and assigned to the Physical Medicine review panel. The statutory decision date of record is 2022-10-14.
- Submission: K220994
- Applicant / Sponsor: Ncs Lab Srl
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5850
- Decision date: 2022-10-14
Classification & Regulation
This clearance is catalogued under FDA product code IPF and 21 CFR 890.5850, within the Physical Medicine review panel as a Class II device.