INDACO SRL

Indaco Srl specializes in orthopedic supports, including lumbar spine orthoses (like the M-Brace Air), clavicle orthoses, and abdominal hernia trusses (such as HPH Corp. and BEST BACK). Their portfolio also covers wrist/hand orthoses, metacarpophalangeal joint extension braces, knee supports, and reusable abdominal/ankle binders (e.g., ACTIVDAY). These devices are designed to provide external support, stabilization, or compression for musculoskeletal conditions.

Indaco Srl is based in the United States, meaning its devices must comply with U.S. regulatory requirements. Since these products are classified as Class I medical devices under FDA regulations, they fall under the FDA’s general controls, which include registration, listing, and UDI requirements. The company’s location ensures alignment with FDA-specific processes for device authorization.

Yes, Indaco Srl’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This matters because the UDI system ensures traceability, transparency, and efficient tracking of medical devices throughout their lifecycle. Listing in the UDI database helps healthcare providers, regulators, and patients verify device details, reducing risks like counterfeiting or misidentification.

Indaco Srl’s devices are classified as Class I under FDA regulations, which is the lowest risk category. This classification implies that the devices pose minimal potential harm and are subject to general controls like good manufacturing practices (GMP), registration, and UDI requirements. Class I devices typically require less rigorous premarket review unless they are custom-designed or present higher risks.