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Deroyal 9011-00 - Shoulder Immobilizer, Cutaway, Pediatric: Stabilization for Pediatric Shoulder Injuries, EACH
Product Overview
The Deroyal 9011-00 Shoulder Immobilizer, Cutaway, Pediatric is specifically designed to provide support and immobilization for pediatric patients with shoulder injuries or post-surgical recovery needs. The cutaway design allows for comfort and ease of use while ensuring that the shoulder remains immobilized in the correct position to promote healing. This shoulder immobilizer is tailored for children, offering the right fit and support needed for their smaller frames.
Constructed from lightweight, breathable materials, this pediatric shoulder immobilizer ensures comfort during extended wear while providing the necessary stabilization to protect the injured shoulder from further damage.
Device Characteristics
Category | Details |
---|---|
MRI Safety Information in Labeling | Labeling does not contain MRI Safety Information |
Required Labeling for Natural Rubber Latex or Dry Natural Rubber (21 CFR 801.437) | No |
Labeled as "Not made with natural rubber latex" | Yes |
For Single-Use | No |
Prescription Use (Rx) | Yes |
Over the Counter (OTC) | No |
Kit | No |
Combination Product | No |
Human Cell, Tissue, or Cellular or Tissue-Based Product (HCT/P) | No |
Key Benefits
- Pediatric-Specific Design: Designed to fit pediatric patients, ensuring proper support and comfort for smaller frames.
- Immobilization for Healing: Effectively immobilizes the shoulder, reducing movement to promote healing after an injury or surgery.
- Cutaway Design for Comfort: The cutaway design enhances comfort by preventing excess pressure on the shoulder and allowing for ease of use.
- Lightweight and Breathable Materials: Made from soft, breathable materials that are gentle on the skin, providing comfort even during extended use.
- Adjustable Straps: Features adjustable straps to ensure a secure fit, allowing healthcare providers or caregivers to adjust the immobilizer as needed for the childs comfort and safety.
Compatibility and Applications
The Deroyal 9011-00 Shoulder Immobilizer, Pediatric is suitable for use in various pediatric care settings, including:
- Post-Surgical Recovery: Provides immobilization and support for children recovering from shoulder surgeries, ensuring proper healing.
- Shoulder Injuries: Helps immobilize the shoulder following dislocations, fractures, or sprains to prevent further injury and allow for proper recovery.
- Orthopedic Clinics: Ideal for use by healthcare professionals treating pediatric patients with shoulder injuries requiring stabilization.
Usage Guidelines
To use the Deroyal 9011-00 Shoulder Immobilizer:
- Place the injured shoulder and arm into the immobilizer, ensuring the shoulder is properly supported and immobilized.
- Adjust the straps to ensure the immobilizer fits snugly and comfortably, providing adequate support without restricting circulation.
- Follow the healthcare providers instructions regarding how long the immobilizer should be worn and when it should be removed for cleaning or physical therapy.
- Regularly check for any signs of discomfort or irritation and adjust the straps as needed.
For more detailed instructions, refer to the product manual or consult with your healthcare provider for proper use.
Certifications, Safety Standards, and Regulatory Approvals
The Deroyal 9011-00 Shoulder Immobilizer meets all necessary safety and quality standards, including:
- FDA Compliance: Approved by the FDA for pediatric use, ensuring that the immobilizer meets stringent safety and performance standards.
- ISO Certification: Manufactured in compliance with ISO 13485 standards, ensuring consistent quality and reliability for pediatric orthopedic devices.
Comparison with Competitor Products
The Deroyal 9011-00 Shoulder Immobilizer stands out due to its pediatric-specific design, offering a better fit and more comfortable experience for children compared to one-size-fits-all immobilizers. The cutaway design adds an extra level of comfort by reducing pressure on the shoulder and allowing for easier movement during daily activities. Its adjustable straps and breathable materials make it more comfortable for long-term wear than many standard immobilizers.
Typical User Profile and Application Scenarios
- Pediatric Post-Surgical Patients: Children recovering from shoulder surgeries who require immobilization to promote healing.
- Injury Recovery: Pediatric patients with shoulder dislocations, fractures, or sprains needing stabilization to prevent further damage during recovery.
- Orthopedic Pediatric Care Providers: Healthcare providers treating children with shoulder injuries or conditions requiring immobilization and support.
Best Practices for Use and Maintenance
- Ensure Proper Fit: Regularly adjust the straps to ensure the immobilizer fits securely and provides adequate support without restricting circulation.
- Clean Regularly: Follow the manufacturers instructions for cleaning the immobilizer to maintain hygiene, especially during extended use.
- Inspect for Wear and Tear: Regularly check the immobilizer for signs of wear or damage and replace it if necessary to ensure continued support and comfort.
Regulatory and Safety Information
The Deroyal 9011-00 Shoulder Immobilizer complies with FDA regulations and ISO standards, ensuring that it meets all necessary safety and quality requirements for pediatric use in orthopedic and recovery settings. These certifications provide healthcare professionals and caregivers with confidence in the products reliability and effectiveness for pediatric shoulder immobilization.
How to Order
To order the Deroyal 9011-00 - Shoulder Immobilizer, Cutaway, Pediatric, visit the CIA Medical website and add the product to your cart. For bulk orders or additional inquiries, contact CIA Medical customer service at (312) 275-5850 or use the contact form on the website for assistance.
Deroyal #9012-00, Adjustable Shoulder Immobilizer, Cutaway: Secure Support for Shoulder Stabilization, EACH
$18.80 EACH
Deroyal #9013-03, Shoulder Immobilizer with Cutaway Sling Medium Size for Comfortable Shoulder Stabilization, EACH
$17.94 EACH
Deroyal #9013-00, Shoulder Immobilizer Sling Cutaway Design for Secure, Comfortable Shoulder Support, EACH
$18.49 EACH
Deroyal #TX9901-01, Arm Sling, Child: Comfortable Support for Pediatric Arm and Shoulder Injuries, EACH
$3.66 EACH