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crutch tips grips
First Industries
Summary: Crutch tips grips by First Industries are designed to enhance stability and comfort for crutch users. Cleared by the FDA in 1981, they are primarily used to prevent slipping and improve grip. Current evidence includes two studies focusing on physical activity and disability prevention.
FDA Clearance Information
Pathway
510K
Number
K810650 ↗
Decision Date
March 26, 1981
Product Code
INP
Device Class
Class 1
Evidence
0 studies
The crutch tips grips by First Industries were cleared through the FDA 510k pathway on March 26, 1981. They are classified as Class 1 devices under product code INP.
What It Is
Crutch tips grips are attachments for crutches that provide enhanced traction and comfort. They are intended to reduce the risk of slipping and improve user stability, particularly in patients requiring mobility assistance.
Clinical Applications
These grips are commonly used in clinical settings for patients with mobility impairments, such as those recovering from surgery or injury. They are particularly beneficial for individuals who rely on crutches for extended periods.
Evidence Summary
The available literature includes two studies registered on ClinicalTrials.gov, focusing on physical activity and disability prevention in postmenopausal women. The studies' details, including sample sizes and outcomes, are not specified.
Reported Outcomes
Published studies report limited data on the specific outcomes related to crutch tips grips. The studies focus on broader themes of physical activity and disability prevention, without detailed findings on the efficacy of the grips themselves.
Safety Profile
Reported complications include no specific adverse events related to the use of crutch tips grips, as the available studies do not provide detailed safety data.
Evidence Limitations
The evidence is limited by the lack of specific data on the efficacy and safety of crutch tips grips. Further research is needed to evaluate their direct impact on mobility and safety in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for crutch tips grips?
The clinical indications are detailed in the FDA documentation, primarily focusing on enhancing stability and comfort for crutch users.
What outcomes have been reported in clinical studies?
The studies focus on physical activity and disability prevention, but specific outcomes related to the grips are not detailed.
What complications have been reported?
The available evidence does not specify any complications directly associated with the use of crutch tips grips.
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.