đź“‹ FDA Reference
model 1553 recliner interface
Invacare
Summary: The Model 1553 Recliner Interface by Invacare is a medical device used in conjunction with recliner chairs to enhance patient comfort and positioning. It is primarily used by healthcare professionals in settings like hospitals and long-term care facilities.
FDA Clearance Information
Pathway
510K
Number
K880362 ↗
Decision Date
September 19, 1988
Product Code
ITI
Device Class
Class 2
Evidence
0 studies
The Model 1553 Recliner Interface was cleared by the FDA via the 510(k) pathway on September 19, 1988. Manufactured by Invacare, it is classified as a Class 2 medical device under product code ITI.
What It Is
The Model 1553 Recliner Interface is designed to be used with recliner chairs to improve patient positioning and comfort. It serves as an interface that can be adjusted to accommodate various patient needs, particularly for those who require prolonged sitting or have mobility issues. The device is constructed to be durable and compatible with a range of recliner models.
Clinical Applications
This device is commonly used in clinical settings such as hospitals, rehabilitation centers, and long-term care facilities. It is particularly beneficial for patients who are bedridden or have limited mobility, as it helps in maintaining proper posture and reducing the risk of pressure sores. Specialties that frequently use this device include geriatrics, rehabilitation medicine, and nursing care.
Indications for Use
The FDA indications suggest that the device is intended for patients who require assistance with positioning and comfort while seated in a recliner. This includes individuals with mobility impairments, those recovering from surgery, or patients with chronic conditions that necessitate prolonged sitting.
Practical Considerations
The Model 1553 Recliner Interface is designed to fit a variety of recliner models, making it versatile for different clinical environments. Clinicians should ensure compatibility with existing recliner chairs and consider patient-specific needs when adjusting the interface. Regular maintenance and inspection are recommended to ensure optimal performance.
Frequently Asked Questions
What is the Model 1553 Recliner Interface used for?
It is used to enhance patient comfort and positioning in recliner chairs, particularly for those with mobility issues or requiring prolonged sitting.
What specialties typically use this device?
Geriatrics, rehabilitation medicine, and nursing care are the specialties that commonly use this device.
What are the FDA-cleared indications?
The device is indicated for use in patients needing assistance with positioning and comfort while seated in a recliner, such as those with mobility impairments or recovering from surgery.
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.