Alva/Amco Pharmacal Companies, Inc.

Alva/Amco Pharmacal Companies, Inc. specializes in single-use exothermic heat therapy devices. These products generate controlled warmth through chemical reactions, providing temporary pain relief without requiring external power. Their most common category is exothermic heat therapy packs and patches, such as BackAid for localized back discomfort and Uricalm for gout-related joint pain.

Alva/Amco Pharmacal Companies, Inc. is based in the United States. As a US manufacturer, its devices must comply with domestic medical device regulations, including registration and classification requirements. The company’s location also means its products are listed in the FDA’s Unique Device Identifier (UDI) database, ensuring traceability and regulatory transparency.

Devices from Alva/Amco Pharmacal Companies, Inc. are registered in the FDA’s Unique Device Identifier (UDI) database. This registry assigns standardized identifiers to medical devices, improving tracking, reporting, and compliance with US regulatory requirements. The UDI system helps ensure transparency and accountability for Class I devices like their exothermic heat therapy products.

All devices manufactured by Alva/Amco Pharmacal Companies, Inc. fall under Class I regulatory classification in the US. This classification applies to low-risk medical devices, such as their exothermic heat therapy packs and patches, which pose minimal risk to patients when used as intended. Class I devices typically require general controls (e.g., manufacturing practices, labeling) but do not undergo premarket approval.