SUPERCHARGE HYDRA FASCIA ELECTRODES

Basic Information

• Brand Name: SUPERCHARGE HYDRA FASCIA ELECTRODES
• Primary DI: 08056182721327
• Version / Model: 16568
• Company Name: UNIBELL SRL
• Labeler DUNS: 338736462
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-03-16
• Public Version: 1
• Public Version Date: 2026-03-24
• Public Version Status: New
• Public Device Record Key: 8908d606-2530-4a58-9a42-0d2b405a9ef7

Device Description

Non-sterile commercial kit containing eight stimulation electrodes packaged together for convenience. The electrodes included in the kit are identical to devices marketed individually and are capacitive electrodes specific for the HCR1002 medical device: Structuranova / Ø 25 mm | sphere Structuranova / Ø 65 mm | thickness 25 mm Structuranova / Ø 90 mm | hickness 25 mm Lymphanova / oval Ømaj 20mm thickness 14mm Lymphanova / oval Ømaj 40mm thickness 14 mm Lymphanova / oval Ømaj 60mm thickness 14 mm Lymphanova / Ø 90 mm | ball Lymphanova / Ø 105 mm tickness 14 mm

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PBX	Massager, Vacuum, Radio Frequency Induced Heat	General, Plastic Surgery	878.4400	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47575	Medium-wave diathermy treatment system	An assembly of devices designed to produce a therapeutic deep heat within specific volumes of the body through the transcutaneous transmission of electromagnetic (EM) energy in the radio-frequency (RF) bands of 0.5 megahertz (MHz) to 1 MHz. It typically consists of an electric generator and two electrodes (active and return) intended to be held on/near the patient. The system is commonly used in outpatient, rehabilitation, traumatology, and sports centre settings to treat pain, muscle spasms, and joint contractures; it is not used for surgery or to treat malignancies.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08056182721327	GS1

Premarket Submissions

Submission Number	Supplement Number
K181211	000