Device, Patient Transfer, Powered
FDA product code FRZ · Class II (moderate risk) · 21 CFR 880.6775 · General Hospital
5510(k) clearances
0PMA approvals
1recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K121929 | Zephyr 'X-Series Patient Transfer SledFRZ · Traditional | Diacor, Inc. | 01/17/2013SE |
| K910830 | InvaliftFRZ · Traditional | American Invalift Corp. | 06/09/1992SE |
| K841728 | Lci Medical Inc Air/PalFRZ · Traditional | Lehigh Consolidated Industries | 06/05/1984SE |
| K834585 | Celltrak-BFRZ · Traditional | R&D Systems, Inc. | 05/02/1984SE |
| K840796 | Tender Lifting CareFRZ · Traditional | Lancer Assoc. | 04/20/1984SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2394-2023 Class II | HoverMatt, 39" W x 78" L, REF: HM39SPU-B39-inche-wide inflatable air transfer mattress packages contain 34-Inch-wide mattresses, so there may be a… | Stryker Sustainability Solutions | 06/21/2023Open, Classified |