Armrest, Wheelchair
A Wheelchair Armrest is a removable or fixed accessory attached to a wheelchair to support the user's arms and upper body during sitting, contributing to positioning, comfort, and pressure management for individuals with mobility impairments. 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 IML, regulated under 21 CFR 890.3920, within the Physical Medicine medical specialty.
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Basic Information
- Product Code
- IML
- Device Class
- FDA class 1
- Regulation Number
- 890.3920
- Medical Specialty
- Physical Medicine
- Review Panel
- PM
- Submission Type
- 4
Device Characteristics
FEI Numbers
This FDA classification entry is associated with 67 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 67 registration numbers. Click on an entry to view related FDA registrations.