đź“‹ FDA Reference
Crutch TIPS Pads Hand Grips
New World Imports
Summary: Crutch tips, pads, and hand grips are accessories for crutches, designed to enhance comfort and safety for users. They are typically used by individuals with mobility impairments.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K800076 ↗
Decision Date ?
January 28, 1980
Product Code ?
INP
Device Class ?
Class 1
Evidence ?
0 studies
This device was cleared through the FDA 510(k) pathway on January 28, 1980. Manufactured by New World Imports, it is classified as a Class 1 device under product code INP.
What It Is
Crutch tips, pads, and hand grips are components used to improve the functionality and comfort of crutches. Crutch tips provide traction and stability, reducing the risk of slipping. Pads and hand grips offer cushioning to prevent discomfort and skin irritation during use. These accessories are essential for enhancing the user experience for individuals relying on crutches for mobility support.
FDA-Cleared Indications
- For use with crutches to provide traction and stability during ambulation.
- For use with crutches to provide cushioning at the underarm support and hand grip areas.
- For use by individuals who require crutches for mobility assistance.
Clinical Applications
- Replacing worn or damaged crutch tips to maintain contact with the walking surface.
- Adding or replacing cushioning on crutch underarm pads.
- Replacing hand grips to improve comfort and handling during crutch use.
- Supporting crutch use during mobility assistance in rehabilitation, outpatient, and home-care settings.
Practical Considerations
- Confirm that the replacement tips, pads, or hand grips fit the specific crutch model and dimensions.
- Inspect components regularly for cracking, flattening, looseness, excessive wear, or loss of traction; replace damaged parts.
- Keep crutch tips clean and dry, and use them on surfaces appropriate for the crutch design.
- These accessories are not a substitute for properly fitted crutches or instruction from a clinician.
- MRI safety depends on the complete crutch assembly and any metallic components; the accessory should not be considered MRI safe without manufacturer-specific information.
Frequently Asked Questions
What is crutch tips pads hand grips used for?
They are used to enhance the safety and comfort of crutches, providing better traction and cushioning for users.
What specialties typically use this device?
Orthopedic and rehabilitation specialists commonly use these accessories, as well as home care providers.
What are the FDA-cleared indications?
These accessories are indicated for use with crutches to assist individuals with mobility impairments, providing additional support and comfort.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.