Product Code: IMN FDA class 1 21 CFR 890.3920

Climber, Curb, Wheelchair

Physical Medicine

A Wheelchair Curb Climber is an accessory attachment for a wheelchair that assists the user or attendant in negotiating small curbs and raised surfaces, improving the wheelchair's ability to traverse minor environmental barriers. 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 IMN, regulated under 21 CFR 890.3920, within the Physical Medicine medical specialty.

510(k)s
0
FEI Numbers
24
Registration Numbers
24
Unique Applicants
0
Years Active

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Basic Information

Product Code
IMN
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 24 FEI numbers. Click on an entry to view related FDA registrations.

Registration Numbers

This FDA classification entry is associated with 24 registration numbers. Click on an entry to view related FDA registrations.