📋 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 ?
510(k)
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.
FDA-Cleared Indications
- Used with compatible recliner chairs to assist with patient positioning while seated.
- Intended to support patient comfort during prolonged sitting.
- Used for patients who need assistance maintaining a suitable seated position.
Clinical Applications
- Supporting seated positioning in a compatible medical recliner.
- Improving comfort for patients who remain seated for extended periods.
- Assisting positioning of patients with limited mobility in hospital or long-term-care settings.
- Providing an adjustable interface between the patient and a compatible recliner chair.
Practical Considerations
- Confirm that the interface is compatible with the specific recliner chair before use.
- Adjust and inspect the interface according to the facility's equipment procedures and the manufacturer's instructions.
- Assess the patient's posture, skin condition, mobility, and ability to reposition; the interface does not replace routine pressure-injury prevention.
- This is a mechanical seating accessory, not an implanted or intravascular device; MRI-specific safety labeling should be confirmed with Invacare before use in an MRI environment.
- The FDA record identifies the device by model and product code, but the supplied information does not specify a range of sizes, weight limits, or service life.
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.