Product Code: FML FDA class 1 21 CFR 880.6140

Chair, Blood Donor

General Hospital

The Blood Donor Chair is a specially designed reclining chair used in blood donation settings to safely and comfortably position donors during the phlebotomy procedure. It is classified as FDA Class 1 (lowest risk) and is subject only to general controls. The product code is FML, regulated under 21 CFR 880.6140 in the General Hospital specialty. This device is exempt from Good Manufacturing Practice (GMP) requirements.

510(k)s
2
FEI Numbers
30
Registration Numbers
30
Unique Applicants
2
Years Active
7

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Basic Information

Product Code
FML
Device Class
FDA class 1
Regulation Number
880.6140
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 2 510(k) clearances via K numbers.

K Number Device Name
K842517 UNILET LANCET
K780181 GLOVES, FLOOR

FEI Numbers

This FDA classification entry is associated with 30 FEI numbers. Click on an entry to view related FDA registrations.

Registration Numbers

This FDA classification entry is associated with 30 registration numbers. Click on an entry to view related FDA registrations.