Device, Transfer, Patient, Manual
The Manual Patient Transfer Device is a non-powered device used to assist in manually moving patients between surfaces such as beds, stretchers, and examination tables with reduced effort and injury risk to both patients and caregivers. It is classified as FDA Class 1 (lowest risk) and is subject only to general controls. The product code is FMR, regulated under 21 CFR 880.6785 in the General Hospital specialty. This device is exempt from Good Manufacturing Practice (GMP) requirements.
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Basic Information
- Product Code
- FMR
- Device Class
- FDA class 1
- Regulation Number
- 880.6785
- 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 |
|---|---|---|---|---|
| K871475 | SOLOLIFT - PATIENT TRANSFER STRETCHER | May 11, 1987 | Substantially Equivalent | Adel Medical , Ltd. |
| K801796 | THE COMFORT LIFT | Aug 13, 1980 | Substantially Equivalent | Gettner Enterprises, Inc. |
| K800373 | TENDERLIFT | Mar 12, 1980 | Substantially Equivalent | Competent Design |
| K792318 | SKIL-CARE TURN AND HOLD PAD | Dec 20, 1979 | Substantially Equivalent | Skil-Care Corp. |
| K770499 | PATIENT TURNING AND REPOSITIONING G DEV. | Apr 29, 1977 | Substantially Equivalent | Patient Healthguards Corp. |
FEI Numbers
This FDA classification entry is associated with 244 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 244 registration numbers. Click on an entry to view related FDA registrations.