FMR · Device, Transfer, Patient, Manual
General Hospital · 21 CFR 880.6785 · Class 1
Overview
| Product Code | FMR |
|---|---|
| Device Name | Device, Transfer, Patient, Manual |
| Regulation | 21 CFR 880.6785 |
| Device Class | Class 1 |
| Review Panel | General Hospital |
| GMP Exempt | Yes |
Identification
A manual patient transfer device is a device consisting of a wheeled stretcher and a mechanism on which a patient can be placed so that the patient can be transferred with minimal disturbance in a horizontal position to the stretcher.
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. The device is also exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.
Recent Cleared Devices (5 of 5)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K871475 | SOLOLIFT - PATIENT TRANSFER STRETCHER | Adel Medical , Ltd. | May 11, 1987 | SESE |
| K801796 | THE COMFORT LIFT | Gettner Enterprises, Inc. | Aug 13, 1980 | SESE |
| K800373 | TENDERLIFT | Competent Design | Mar 12, 1980 | SESE |
| K792318 | SKIL-CARE TURN AND HOLD PAD | Skil-Care Corp. | Dec 20, 1979 | SESE |
| K770499 | PATIENT TURNING AND REPOSITIONING G DEV. | Patient Healthguards Corp. | Apr 29, 1977 | SESE |
Top Applicants
- Adel Medical , Ltd. — 1 clearance
- Competent Design — 1 clearance
- Gettner Enterprises, Inc. — 1 clearance
- Patient Healthguards Corp. — 1 clearance
- Skil-Care Corp. — 1 clearance
