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computerized orthopaedic pedotopography machine
Nathaniel Gould Diagnostics
Summary: The computerized orthopaedic pedotopography machine by Nathaniel Gould Diagnostics is used for detailed mapping of foot pressure distribution. It is primarily utilized by orthopedic specialists and podiatrists to assess and diagnose foot-related conditions.
FDA Clearance Information
Pathway
510K
Number
K881284 ↗
Decision Date
July 21, 1988
Product Code
JFC
Device Class
Class 1
Evidence
0 studies
This device was cleared through the FDA 510k pathway on July 21, 1988, by Nathaniel Gould Diagnostics. It is classified as a Class 1 device under product code JFC.
What It Is
The computerized orthopaedic pedotopography machine is a diagnostic tool designed to measure and map pressure distribution across the foot. It uses sensors to capture data on how weight is distributed when a patient stands or walks, providing valuable insights into foot mechanics. This information is crucial for diagnosing conditions like flat feet, plantar fasciitis, and other orthopedic issues.
Clinical Applications
This device is commonly used in orthopedic and podiatric settings to evaluate patients with foot pain, gait abnormalities, or structural foot deformities. It is particularly useful in assessing patients with diabetes for neuropathy-related foot issues. The device aids in creating custom orthotics and planning surgical interventions by providing precise pressure mapping.
Indications for Use
The FDA indications suggest this device is used for assessing foot pressure distribution, which is vital in diagnosing and managing conditions affecting foot mechanics. It is suitable for patients with foot pain, gait issues, or those requiring custom orthotic solutions.
Practical Considerations
The device typically comes in various sizes to accommodate different foot sizes and is compatible with most clinical settings. Proper calibration and technique are essential for accurate readings, and clinicians should ensure the device is used on a flat, stable surface for optimal results.
Frequently Asked Questions
What is the computerized orthopaedic pedotopography machine used for?
It is used for mapping foot pressure distribution to diagnose and manage foot-related conditions.
What specialties typically use this device?
Orthopedic specialists and podiatrists commonly use this device.
What are the FDA-cleared indications?
The device is indicated for assessing foot pressure distribution, aiding in the diagnosis and management of foot mechanics-related conditions.
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.