Device, Anti-Tip, Wheelchair
A Wheelchair Anti-Tip Device is a safety attachment fitted to the rear of a wheelchair to prevent the chair from tipping backward, protecting the user from falls especially on inclines, when reaching, or during propulsion on uneven surfaces. 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 IMR, regulated under 21 CFR 890.3920, within the Physical Medicine medical specialty.
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Basic Information
- Product Code
- IMR
- 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 56 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 56 registration numbers. Click on an entry to view related FDA registrations.