Moonachie, NJ, US · 4 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| JOW | Sleeve, Limb, Compressible | Class II | Cardiovascular | 3 | 2026-09-11 |
| IRP | Massager, Powered Inflatable Tube | Class II | Physical Medicine | 1 | 2022-02-16 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-09-11 | K261807 | Sequential Circulator (SC-4004-DL, SC-4008-DL) | JOW | Class II | Cardiovascular |
| 2025-12-12 | K250974 | Bio Arterial Deluxe (IC-BAP-DX) | JOW | Class II | Cardiovascular |
| 2022-02-16 | K213533 | Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-DL, SC-4008-DL | IRP | Class II | Physical Medicine |
| 2021-05-14 | K210417 | Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-DL, SC-4008-DL | JOW | Class II | Cardiovascular |