Product Code: IMW FDA class 1 21 CFR 890.3920

Brake, Extension, Wheelchair

Physical Medicine

A Wheelchair Brake Extension is an accessory that lengthens the brake lever handle on a wheelchair, enabling users with limited hand reach, strength, or dexterity to engage and disengage the wheelchair brakes more easily and safely. 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 IMW, regulated under 21 CFR 890.3920, within the Physical Medicine medical specialty.

510(k)s
0
FEI Numbers
42
Registration Numbers
42
Unique Applicants
0
Years Active

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Basic Information

Product Code
IMW
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 42 FEI numbers. Click on an entry to view related FDA registrations.

Registration Numbers

This FDA classification entry is associated with 42 registration numbers. Click on an entry to view related FDA registrations.