Shoulder PacemakerTM
by Ncs Lab SRL
510(k) K220994
Shoulder PacemakerTM is a Class II device made by Ncs Lab SRL, cleared under FDA 510(k) K220994 on 14 Oct 2022, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK220994 | Date14 Oct 2022 | StatusActive |
Official records
- FDA 510(k) database K220994
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- IPF
- Device class
- Class II
- Regulation
- 21 CFR Part 890.5850
- Advisory committee
- Physical Medicine
- FDA decision
- SESE Substantially Equivalent
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