Devices marketed with therapeutic or medical claims may be regulated as medical devices under FDA authority, requiring the importer to ensure the product is properly registered, labeled, and cleared or exempt before entry. Purely cosmetic or general-wellness massage products typically face a lower regulatory burden, but the line between the two is fact-specific. Consult a licensed customs broker or regulatory counsel to confirm admissibility status.

Mechano-therapy appliances operate through mechanical action — vibration, compression, traction, or manipulation — rather than electrical stimulation of tissue. Electrotherapy devices (e.g., TENS units, ultrasound therapy) fall under separate headings. The operating principle and primary mode of therapeutic action are the key classification criteria; devices combining both modalities require a principal-use or essential-character determination.