Product code FRZ— General Hospital

FDA has cleared 5 devices under product code FRZ between 1984 and 2013, filed by 5 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

• 20131 clearance
• 19921 clearance
• 19843 clearances

• R&D Systems, Inc.1 clearance
• Lehigh Consolidated Industries1 clearance
• Lancer Assoc.1 clearance
• Diacor, Inc.1 clearance
• American Invalift Corp.1 clearance

Other

1

Total

1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• K121929 — ZEPHYR 'X-SERIES PATIENT TRANSFER SLEDDiacor, Inc.·2013-01-17
• K910830 — INVALIFTAmerican Invalift Corp.·1992-06-09
• K841728 — LCI MEDICAL INC AIR/PALLehigh Consolidated Industries·1984-06-05
• K834585 — CELLTRAK-BR&D Systems, Inc.·1984-05-02
• K840796 — TENDER LIFTING CARELancer Assoc.·1984-04-20