FSA · Lift, Patient, Non-Ac-Powered
General Hospital · 21 CFR 880.5510 · Class 1
Overview
| Product Code | FSA |
|---|---|
| Device Name | Lift, Patient, Non-Ac-Powered |
| Regulation | 21 CFR 880.5510 |
| Device Class | Class 1 |
| Review Panel | General Hospital |
Identification
A non-AC-powered patient lift is a hydraulic, battery, or mechanically powered device, either fixed or mobile, used to lift and transport a patient in the horizontal or other required position from one place to another, as from a bed to a bath. The device includes straps and a sling to support the patient.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9.
Recent Cleared Devices (13 of 13)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K942807 | SURGICAL LIFT SHEET | Surgin Surgical Instrumentation, Inc. | Aug 2, 1994 | SESE |
| K930625 | SANITAS PATIENT LIFT | Dutton-Lainson Co. | Sep 13, 1993 | SESE |
| K902141 | ANOLIFT - PORTABLE & ANOLIFT - GANTRY | Anodyne Corp. | Sep 12, 1990 | SESE |
| K860837 | HOYER ONE-TOUCH POWER LIFTER | Ted Hoyer & Co., Inc. | Mar 27, 1986 | SESE |
| K851844 | MOLIFT | Madshus A/S | May 17, 1985 | SESE |
| K844976 | MEDI-MAN WATER POWERED BATH LIFT & HYDRAULIC LIFT | Medi-Man Rehabilitation Products, Inc. | Apr 1, 1985 | SESE |
| K841398 | VARIABLE HEIGHT TRANSFER CHAIR | Setma, Inc. | May 7, 1984 | SESE |
| K841395 | SHOWER TROLLEY | Setma, Inc. | May 7, 1984 | SESE |
| K840997 | BATTERY POWERED PATIENT LIFT | Invacare Corp. | Apr 17, 1984 | SESE |
| K823206 | MARTIN PELVIC LIFT | Martin Pelvic Lift Co. | Apr 28, 1983 | SESE |
| K811899 | CENTURY LIFT TRANSFER SYSTEM | Century Manufacturing Co. | Jul 23, 1981 | SESE |
| K792601 | LIFELIFT MODELS ONE AND TWO | Corda Int'L Holiday, Inc. | Dec 31, 1979 | SESE |
| K780684 | PATIENT LIFT | Orthopedic Equipment Co., Inc. | Jun 6, 1978 | SESE |
Top Applicants
- Setma, Inc. — 2 clearances
- Anodyne Corp. — 1 clearance
- Century Manufacturing Co. — 1 clearance
- Corda Int'L Holiday, Inc. — 1 clearance
- Dutton-Lainson Co. — 1 clearance
