PAIN POINT MEDICAL SYSTEMS INC.

Pain Point Medical Systems Inc. specializes in external electric-heating core temperature regulation systems. Their primary product, the MiBo Heating Pad Mask, is designed to maintain or restore patient temperature in medical settings through controlled heating. This device is intended for use in clinical environments where precise temperature management is critical.

Pain Point Medical Systems Inc. is headquartered in the United States. The company’s location is relevant for understanding its regulatory framework, as it operates under U.S. medical device compliance standards.

Pain Point Medical Systems Inc.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps ensure traceability and transparency in the medical device supply chain, allowing healthcare providers and regulators to verify device details.

Pain Point Medical Systems Inc.’s devices fall under the FDA’s Class II regulatory classification. This classification is assigned based on the device’s risk level and intended use, requiring compliance with specific controls to ensure safety and effectiveness without needing the same rigorous pre-market approval process as Class III devices.