Customization:
With FDA-registered and CE-certified medical-grade polymer materials, you can ensure safety and compliance for orthopedic rehabilitation. The eco-friendly design aligns with EPR Germany Packaging standards, reducing environmental impact compared to non-compliant alternatives*.
With re-moldable thermoplastic properties activated at low temperatures, you can easily customize the splint to fit individual patient needs without requiring high-heat equipment, simplifying clinical or home use*.
With strategically placed perforations, you can improve airflow and skin comfort during prolonged use, addressing a common issue in traditional non-perforated splints*.
With a 3-year shelf life and adaptability to low-temperature reshaping, you can deploy this splint in both clinical and home settings for orthopedic rehabilitation, offering long-term durability compared to shorter-shelf-life alternatives*.
With Class I medical device certification (FDA and CE ISO), you can trust compliance with global safety and quality benchmarks, ensuring reliability over uncertified or non-standardized products*.
The Re-Moldable Low-Temperature Plastics Eco Sheet Perforated Thermoplastic Splint is a versatile medical consumable designed for orthopedic physiotherapy and rehabilitation. Crafted from medical-grade polymer materials, it offers customizable flexibility, durability, and perforated design for breathability and adaptability. Certified by FDA and CE/ISO standards, it ensures safety and compliance for clinical and home-use environments.
Feature | Specification | Benefit |
---|---|---|
Material | Medical-grade polymer/plastic (low-temperature moldable) | Lightweight yet durable, enabling easy reshaping during therapy sessions. |
Certifications | FDA Registration, CE ISO, EPR Germany Packing | Guaranteed safety and environmental compliance for global use. |
Safety Standards | CE-certified, ISO-compliant | Meets rigorous medical-grade safety and quality benchmarks. |
Shelf Life | 3 years | Long-lasting storage without degradation, ideal for stock management. |
Perforation Design | Uniform circular holes (5mm diameter), customizable patterns | Enhances breathability and reduces skin irritation during prolonged use. |
Instrument Class | Class I Medical Device | Simplifies regulatory compliance for clinics and healthcare providers. |
Adjustable parameters include sheet thickness (2–5mm), perforation density, and color options (white, beige, blue) to meet specific patient needs. For instance, denser perforations can improve airflow in hot climates, while thicker sheets offer extra support for high-impact therapies.
With its perforated design and moldable properties, this splint adapts seamlessly to diverse rehabilitation scenarios. Whether supporting post-surgery recovery or aiding mobility exercises, its lightweight yet sturdy build ensures comfort and efficacy.
Parameter | Base Model | Advanced Model | Pro Model |
---|---|---|---|
Moldability Temperature | 60°C | 55°C (15% cooler) | 50°C (30% cooler)* |
Sheet Thickness Range | 2–3mm | 3–4mm | 4–5mm |
Custom Perforation Options | Pre-set patterns | 3 customizable patterns | Full pattern design |
Durability Rating | Standard | 20% stronger | 40% stronger* |
Technical Breakthroughs:
Optimal Version Selection:
Example Use Case: With the Pro Model’s 40% stronger material and 50°C moldability, therapists can create splints for patients with fragile skin or complex fractures, ensuring both safety and precision.
Category | Usage Scenarios | Characteristics | Advantages | Disadvantages |
---|---|---|---|---|
Material Composition | Orthopedic splints, prosthetics | Industry: Basic plastics (ASTM D648) | Our Base: Medical-grade polymer (ISO 10993 biocompatibility) ▲ | Our Advanced: Eco-friendly polymer (ASTM D648 + EPR Germany compliance) ▲▲ |
Enhanced durability and reduced skin irritation (Base) | Full recyclability and EPR compliance (Advanced) | |||
Base: Lightweight yet sturdy for patient comfort | Advanced: Higher cost due to eco-materials |
| Safety Compliance | Hospital/clinic equipment | Industry: CE-only certification | Our Base: CE + FDA Registration (Class I medical device) ▲ | Our Advanced: CE + FDA + EPR Germany Packing ▲▲ |
| | | | Expands market access to U.S. and EU markets | Meets strict German environmental regulations for recyclability |
| | | | Base: Simplified regulatory compliance | Advanced: Requires additional testing for EPR certification |
| Shelf Life | Long-term medical storage | Industry: 2 years (ISO 11607) | Our Base: 3 years (ISO 11607) ▲ | Our Advanced: 4 years (accelerated aging test) ▲▲ |
| | | | Reduces waste and restocking frequency | Extended shelf life via advanced polymer stability |
| | | | Base: Matches industry standards for most clinics | Advanced: Requires controlled storage conditions |
| Customization | Patient-specific splints | Industry: Limited sizes/colors (stock items) | Our Base: Adjustable molds + 5 standard colors ▲ | Our Advanced: Full color/size customization + perforation pattern tweaks ▲▲ |
| | | | Faster adaptation to patient needs | Tailored designs reduce readjustment time |
| | | | Base: Adequate for general use | Advanced: Higher production costs for bespoke orders |
| Ease of Use | Physiotherapy sessions | Industry: High-temperature molding (>80°C) | Our Base: Low-temperature molding (60°C) ▲ | Our Advanced: Ultra-low-temperature molding (40°C) + faster setting ▲▲ |
| | | | Safer for patient application (reduced burn risk) | Ideal for pediatric or sensitive-skin patients |
| | | | Base: Requires basic heat tools | Advanced: Simplifies workflow for untrained staff |
| Environmental Impact | Eco-conscious healthcare facilities | Industry: Non-recyclable materials | Our Base: Recyclable (ISO 14021 compliant) ▲ | Our Advanced: Biodegradable (OK Compost certification) ▲▲ |
| | | | Reduces landfill waste | Fully compostable for zero-waste facilities |
| | | | Base: Meets basic recycling standards | Advanced: Higher material cost and niche adoption |
The Product Description is generated by third-party, and Alibaba.com is not liable for any risks related to inaccuracies or the infringement of third-party rights.
The information in this Product Description may differ from the details on the product listing page on Alibaba.com. Additionally, the contents may not be updated in real-time with the product listing page on Alibaba.com, and there may be delays in reflecting the most updated information. The description on product listing page takes precedence. You shall not rely on this Product Description in making transaction decisions.
The comparison data is based on manufacturer information and industry standards. Actual results may vary depending on individual use cases. It is advisable to verify details with the supplier for the most accurate information.