Device, Patient Transfer, Powered
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.
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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
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K121929 | ZEPHYR 'X-SERIES PATIENT TRANSFER SLED | Jan 17, 2013 | Substantially Equivalent | Diacor, Inc. |
| K910830 | INVALIFT | Jun 09, 1992 | Substantially Equivalent | American Invalift Corp. |
| K841728 | LCI MEDICAL INC AIR/PAL | Jun 05, 1984 | Substantially Equivalent | Lehigh Consolidated Industries |
| K834585 | CELLTRAK-B | May 02, 1984 | Substantially Equivalent | R&D Systems, Inc. |
| K840796 | TENDER LIFTING CARE | Apr 20, 1984 | Substantially Equivalent | Lancer Assoc. |
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.