Inspirstar, Inc.

Inspirstar, Inc. specializes in transcutaneous neuromuscular electrical stimulation (NMES) systems, which are primarily used in physical therapy. Their portfolio includes microcurrent stimulators and disposable glove electrodes, designed to aid in muscle stimulation and rehabilitation. These devices are intended for therapeutic applications where electrical stimulation helps improve muscle function or recovery.

Inspirstar, Inc. is based in the United States. Their devices are registered and authorized for use in the U.S. market, where they comply with FDA regulations. The company’s products are listed through pathways like the 510(k) premarket notification process and the Unique Device Identifier (UDI) system, which are standard for Class II devices in this jurisdiction.

Inspirstar’s devices are classified as Class II under FDA regulations. This classification is typically assigned to devices that pose moderate risk and require special controls to ensure their safety and effectiveness. For NMES systems like those produced by Inspirstar, these controls may include performance standards, labeling requirements, and post-market surveillance to mitigate risks such as improper use or electrical hazards, ensuring they meet regulatory expectations for therapeutic electrical stimulation devices.

Inspirstar’s devices are listed in the FDA’s 510(k) premarket notification database and the Unique Device Identifier (UDI) system. These registries are used to track and verify the authorization status of medical devices in the U.S. The 510(k) pathway demonstrates that the company’s devices are substantially equivalent to legally marketed predicates, while the UDI system ensures traceability and transparency in the supply chain for Class II devices like theirs.