Product Code: IMM FDA class 1 21 CFR 890.3920

Footrest, Wheelchair

Physical Medicine

A Wheelchair Footrest is an adjustable or fixed platform attached to a wheelchair to support the user's feet and lower legs, maintaining proper positioning and preventing foot drag during wheelchair propulsion and transfers. It is classified as FDA Class 1, the lowest risk category, subject only to general controls with no premarket submission required. The product code is IMM, regulated under 21 CFR 890.3920, within the Physical Medicine medical specialty.

510(k)s
2
FEI Numbers
64
Registration Numbers
64
Unique Applicants
2
Years Active
7

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Basic Information

Product Code
IMM
Device Class
FDA class 1
Regulation Number
890.3920
Medical Specialty
Physical Medicine
Review Panel
PM
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
K892791 PATIENT EXAMINATION GLOVES (LATEX)
K821634 EZ STAND MOBILE STOOL

FEI Numbers

This FDA classification entry is associated with 64 FEI numbers. Click on an entry to view related FDA registrations.

Registration Numbers

This FDA classification entry is associated with 64 registration numbers. Click on an entry to view related FDA registrations.