Brake, Extension, Wheelchair
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.
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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
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.