Product Code: IMR FDA class 1 21 CFR 890.3920

Device, Anti-Tip, Wheelchair

Physical Medicine

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.

510(k)s
0
FEI Numbers
56
Registration Numbers
56
Unique Applicants
0
Years Active

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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

GMP Exempt
Implant
Life Sustain/Support
Third Party
Summary Malfunction Reporting

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.