Product Code: FMR FDA class 1 21 CFR 880.6785

Device, Transfer, Patient, Manual

General Hospital

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.

510(k)s
5
FEI Numbers
244
Registration Numbers
244
Unique Applicants
5
Years Active
10

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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

GMP Exempt
Implant
Life Sustain/Support
Third Party
Summary Malfunction Reporting

510(k) Clearance History

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Related 510(k) Clearances

This FDA classification is associated with 5 510(k) clearances via K numbers.

K Number Device Name
K871475 SOLOLIFT - PATIENT TRANSFER STRETCHER
K801796 THE COMFORT LIFT
K800373 TENDERLIFT
K792318 SKIL-CARE TURN AND HOLD PAD
K770499 PATIENT TURNING AND REPOSITIONING G DEV.

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.