Product Code: KHY FDA class 1 21 CFR 890.3075

Cane, Safety Walk

Physical Medicine

Safety Walk Cane is a mobility aid device used to assist individuals with walking difficulties, gait impairments, or balance problems by providing additional stability and a point of contact with the ground, commonly prescribed in physical medicine and rehabilitation settings. It is classified as FDA Class 1, the lowest risk category, subject to general controls only, meaning it does not require premarket notification or approval. The product code is KHY, regulated under 21 CFR 890.3075, within the Physical Medicine medical specialty. This device is exempt from Good Manufacturing Practice (GMP) regulations.

510(k)s
0
FEI Numbers
46
Registration Numbers
46
Unique Applicants
0
Years Active

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Basic Information

Product Code
KHY
Device Class
FDA class 1
Regulation Number
890.3075
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 46 FEI numbers. Click on an entry to view related FDA registrations.

Registration Numbers

This FDA classification entry is associated with 46 registration numbers. Click on an entry to view related FDA registrations.