Product Code: FRZ FDA class 2 21 CFR 880.6775

Device, Patient Transfer, Powered

General Hospital

A powered patient transfer device is a motorized or actuator-assisted piece of equipment used to safely move patients between surfaces such as beds, gurneys, or wheelchairs, reducing manual handling injuries. It is classified as FDA Class 2 (moderate risk), subject to general and special controls, and requires 510(k) premarket notification. The product code is FRZ, regulated under 21 CFR 880.6775, within the General Hospital medical specialty. No special flags apply to this device.

510(k)s
5
FEI Numbers
56
Registration Numbers
56
Unique Applicants
5
Years Active
29

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Basic Information

Product Code
FRZ
Device Class
FDA class 2
Regulation Number
880.6775
Medical Specialty
General Hospital
Review Panel
HO
Submission Type
4

Device Characteristics

GMP Exempt
Implant
Life Sustain/Support
Third Party
Summary Malfunction Reporting

510(k) Clearance History

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Related 510(k) Clearances

This FDA classification is associated with 5 510(k) clearances via K numbers.

K Number Device Name
K121929 ZEPHYR 'X-SERIES PATIENT TRANSFER SLED
K910830 INVALIFT
K841728 LCI MEDICAL INC AIR/PAL
K834585 CELLTRAK-B
K840796 TENDER LIFTING CARE

FEI Numbers

This FDA classification entry is associated with 56 FEI numbers. Click on an entry to view related FDA registrations.

Registration Numbers

This FDA classification entry is associated with 56 registration numbers. Click on an entry to view related FDA registrations.