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510(k) Data Aggregation
K Number
K241733Device Name
HEBE (NP0000763); HERA (NP0000706)
Manufacturer
Novasonix Technology S.L
Date Cleared
2025-04-16
(303 days)
Product Code
PBX
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
Novasonix Technology S.L
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
HEBE is intended to provide topical heating to elevate tissue temperature for the treatment of selected medical conditions, including pain relief, muscle spasm reduction, and increased local circulation.
Device Description
HEBE is a device indicated for radiofrequency (RF) treatments at 448kHz. This frequency is associated with pain reduction and improved functionality in patients with musculoskeletal disorders. This wavelength promotes ion mobilization between the intracellular and extracellular matrix and restores cell membrane permeability. The energy generated at 448 kHz improves cell membrane permeability, enhancing intracellular and extracellular exchange and tissue regeneration. Furthermore, high-intensity radiofrequency treatment at 448 kHz can induce significant hyperthermia, which can lead to a considerable increase in cell metabolism and accelerated recovery. These hyperthermal adaptations to radiofrequency treatment are based on vasodilatation, causing a targeted local increase of blood perfusion and decreases in muscle tension and spasm, increased oxygen and nutrient supply, and healing acceleration.
RF treatment can be applied through either capacitive or resistive electrodes that pass radiofrequency to the human body.
HEBE has 3 different technologies:
- Monopolar Capacitive Radiofrequency
- Monopolar Resistive Radiofrequency
- Bipolar Resistive Radiofrequency
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