Product Code: IMP FDA class 1 21 CFR 890.3920

Cushion, Wheelchair

Physical Medicine

A Wheelchair Cushion is a seating support accessory placed on the wheelchair seat surface to distribute pressure, reduce shear forces, and provide postural support for individuals with mobility impairments, commonly used to prevent and manage pressure injuries. 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 IMP, regulated under 21 CFR 890.3920, within the Physical Medicine medical specialty.

510(k)s
2
FEI Numbers
167
Registration Numbers
167
Unique Applicants
2
Years Active
2

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Basic Information

Product Code
IMP
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
K890653 ULTIMA WHEELCHAIR CUSHION
K871006 EDCOOL AND EDCOOL JR. INSTANT COLD PACK

FEI Numbers

This FDA classification entry is associated with 167 FEI numbers. Click on an entry to view related FDA registrations.

Registration Numbers

This FDA classification entry is associated with 167 registration numbers. Click on an entry to view related FDA registrations.