PRO MEDICAL SUPPLIES, INC.

Pro Medical Supplies, Inc. specializes in three primary categories of therapeutic devices: single-use transcutaneous electrical stimulation electrodes (like StimPatch or ProPatch), electric pads designed for localized body heating (such as ProMed or EcoPatch), and handheld electric massagers (e.g., ProM-555 or PM-355). These products are intended for medical or therapeutic use, often to relieve pain, reduce inflammation, or improve circulation.

Pro Medical Supplies, Inc. is based in the United States. Since the company operates within the U.S., its devices are subject to FDA regulations, including classification under FDA’s risk-based system (Class I or Class II). This means their products must comply with U.S. medical device standards and may appear in registries like the FDA’s 510(k) database or UDI (Unique Device Identification) system if applicable.

Some devices from Pro Medical Supplies, Inc. are listed in the FDA’s 510(k) premarket notification registry and the UDI system. The 510(k) registry includes devices deemed substantially equivalent to predicate devices, requiring FDA review before commercialization. The UDI system ensures traceability and transparency in the supply chain by assigning unique identifiers to medical devices, aiding tracking and compliance. Listing in these registries depends on the device’s classification and regulatory pathway.

Pro Medical Supplies, Inc.’s devices are classified under FDA’s Class I or Class II categories. Class I devices pose minimal risk and typically require general controls (e.g., labeling, manufacturing practices) for compliance. Class II devices involve moderate risk and may require additional controls, such as performance standards or post-market surveillance. The classification determines the regulatory scrutiny and requirements each device must meet before authorization.