ELITE MEDICAL SUPPLY OF NY

Elite Medical Supply of NY specializes in electrodes and stimulators for physical therapy. Their product line includes rectangular and square fabric electrodes, such as the 2x4" and 2" square variants, designed for transcutaneous neuromuscular electrical stimulation (TENS) and interferential electrical stimulation systems. They also produce multi-mode stimulators, which deliver targeted electrical therapy for muscle stimulation and pain management.

Elite Medical Supply of NY is based in the United States. This means their devices are subject to U.S. regulatory requirements, including compliance with FDA standards for electrical stimulation equipment. Their operations align with applicable U.S. medical device regulations, ensuring their products meet necessary safety and performance criteria.

Elite Medical Supply of NY’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify their Class II devices, ensuring transparency and traceability in the medical device supply chain.

Elite Medical Supply of NY’s devices fall under Class II classification by the FDA. This classification applies to devices that generally pose moderate risk and require special controls beyond general controls to ensure safety and effectiveness. Examples include their electrodes and stimulators, which are regulated to mitigate risks like improper electrical stimulation or skin irritation.