HMP 4000 Interferential Stimulator

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K924961 ↗

FDA Product Code

LIH

Device Class

Class II

Regulation

21 CFR Part 882.5890

Advisory Committee

Neurology

FDA Decision

SESE Substantially Equivalent

• What is the primary clinical application of the HMP 4000 Interferential Stimulator, and how does it work?

  The HMP 4000 Interferential Stimulator is designed to deliver interferential current therapy, a technique that generates electrical currents intersecting to produce a therapeutic effect. It is primarily used in neurology settings to alleviate pain, reduce muscle spasms, and improve circulation in patients with neurological or musculoskeletal conditions. The device achieves this by creating a localized therapeutic zone where the interfering currents stimulate nerve pathways and muscle tissue.

• Is the HMP 4000 Interferential Stimulator intended for single-use or reusable clinical applications?

  The HMP 4000 Interferential Stimulator is explicitly described as a reusable medical instrument, meaning it is built for repeated use in clinical environments. However, standard electrical safety protocols and facility-specific cleaning procedures must be followed to maintain its functionality and ensure patient safety.

• What regulatory pathway was followed for FDA clearance of this device, and what does that mean for its use?

  The HMP 4000 Interferential Stimulator received FDA 510(k) clearance (K924961) under the Traditional 510(k) Review pathway, with a decision classification of *Substantially Equivalent* to a predicate device. This means the FDA determined it has the same intended use and technological characteristics as a previously cleared device, ensuring it meets safety and effectiveness standards for interferential current therapy in neurology. The clearance is specific to the U.S. market.

• Are there any special storage requirements for the HMP 4000 Interferential Stimulator, or does it require sterilization before use?

  The provided data does not specify any sterility requirements or special storage conditions for the HMP 4000 Interferential Stimulator. However, as a reusable device, it should be stored in a clean, dry environment away from direct sunlight or extreme temperatures. Standard electrical safety protocols (e.g., proper grounding, protection from moisture) should be followed, and facility protocols for cleaning and maintenance must be adhered to before each use.

• What product code and regulatory classification does the HMP 4000 Interferential Stimulator fall under, and how does that affect its distribution?

  The HMP 4000 Interferential Stimulator is assigned the product code LIH under the FDA’s classification system, which categorizes it as a Class II device (as noted in OpenFDA data). This classification means it is subject to special controls (e.g., performance standards, labeling requirements) to ensure its safety and effectiveness. The device is authorized for distribution only in the United States, as its clearance (K924961) is specific to this regulatory route.