FRZ · Device, Patient Transfer, Powered
General Hospital · 21 CFR 880.6775 · Class 2
Overview
| Product Code | FRZ |
|---|---|
| Device Name | Device, Patient Transfer, Powered |
| Regulation | 21 CFR 880.6775 |
| Device Class | Class 2 |
| Review Panel | General Hospital |
Identification
A powered patient transfer device is a device consisting of a wheeled stretcher and a powered mechanism that has a broad, flexible band stretched over long rollers that can advance itself under a patient and transfer the patient with minimal disturbance in a horizontal position to the stretcher.
Classification Rationale
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.
Special Controls
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.
Recent Cleared Devices (5 of 5)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K121929 | ZEPHYR 'X-SERIES PATIENT TRANSFER SLED | Diacor, Inc. | Jan 17, 2013 | SESE |
| K910830 | INVALIFT | American Invalift Corp. | Jun 9, 1992 | SESE |
| K841728 | LCI MEDICAL INC AIR/PAL | Lehigh Consolidated Industries | Jun 5, 1984 | SESE |
| K834585 | CELLTRAK-B | R&D Systems, Inc. | May 2, 1984 | SESE |
| K840796 | TENDER LIFTING CARE | Lancer Assoc. | Apr 20, 1984 | SESE |
Top Applicants
- American Invalift Corp. — 1 clearance
- Diacor, Inc. — 1 clearance
- Lancer Assoc. — 1 clearance
- Lehigh Consolidated Industries — 1 clearance
- R&D Systems, Inc. — 1 clearance
