Product Code: INA FDA class 1 21 CFR 890.3920

Hill Holder, Wheelchair

Physical Medicine

A Wheelchair Hill Holder is a safety accessory attached to a wheelchair that provides a ratcheting or locking mechanism to prevent the wheelchair from rolling backward on inclines, improving safety when ascending or pausing on sloped 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 INA, regulated under 21 CFR 890.3920, within the Physical Medicine medical specialty.

510(k)s
0
FEI Numbers
19
Registration Numbers
19
Unique Applicants
0
Years Active

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Basic Information

Product Code
INA
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 19 FEI numbers. Click on an entry to view related FDA registrations.

Registration Numbers

This FDA classification entry is associated with 19 registration numbers. Click on an entry to view related FDA registrations.