SUPERCHARGE HYDRA FASCIA ELECTRODES

Primary DI
08056182721327
Brand
SUPERCHARGE HYDRA FASCIA ELECTRODES
Company
UNIBELL SRL
Model
16568
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 sphereStructuranova / Ø 65 mm thickness 25 mm Structuranova / Ø 90 mm hickness 25 mmLymphanova / oval Ømaj 20mm thickness 14mmLymphanova / oval Ømaj 40mm thickness 14 mmLymphanova / oval Ømaj 60mm thickness 14 mmLymphanova / Ø 90 mm ballLymphanova / Ø 105 mm tickness 14 mm
Published
2026-03-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
PBXMassager, Vacuum, Radio Frequency Induced Heat

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PBXMassager, Vacuum, Radio Frequency Induced HeatGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K181211000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K181211000Human Tecar HCR 1002Unibell S.R.L2018-09-10PBX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08056182721327PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08056182721327080561827213278056182721327

GMDN Terms#

Term, Definition table
TermDefinition
Medium-wave diathermy treatment systemAn 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
338736462
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08056182720634SUPERCHARGE HYDRA FASCIA ELECTRODESStructuranova Ø 65 mm 176822026-03-16
08056182721143SUPERCHARGE HYDRA FASCIA ELECTRODESLymphanova oval Ømaj 40mm177292026-03-16
08056182721167SUPERCHARGE HYDRA FASCIA ELECTRODESLymphanova oval Ømaj 60mm 177302026-03-16
08056182721174SUPERCHARGE HYDRA FASCIA ELECTRODESStructuranova Ø 25 mm177312026-03-16
08056182721181SUPERCHARGE HYDRA FASCIA ELECTRODESLymphanova Ø 90 mm 177322026-03-16
08056182721198SUPERCHARGE HYDRA FASCIA ELECTRODESLymphanova Ø 105 mm177332026-03-16
08056182721204SUPERCHARGE HYDRA FASCIA ELECTRODESLymphanova oval Ømaj 20mm177342026-03-16
08056182721211SUPERCHARGE HYDRA FASCIA ELECTRODESStructuranova Ø 90 mm 177352026-03-16
08056182720283Human Tecar HCR 1002165762019-06-15
08056182720832Human Tecar CAP electrode Ø 30 mm164582019-06-15
08056182720849Human Tecar CAP electrode Ø 40 mm164592019-06-15
08056182720856Human Tecar CAP electrode Ø 55 mm164602019-06-15
08056182720863Human Tecar CAP electrode Ø 65 mm164612019-06-15
08056182720870Human Tecar CAP electrode Ø 80 mm164622019-06-15
08056182720887Human Tecar CAP electrode Ø 55 mm164692019-06-15
08056182720894Human Tecar CAP electrode convex Ø 30 mm164632019-06-15
08056182720900Human Tecar CAP electrode convex Ø 40 mm164642019-06-15
08056182720917Human Tecar CAP electrode convex Ø 55 mm164652019-06-15
08056182720924Human Tecar CAP electrode convex Ø 65 mm164662019-06-15
08056182720931Human Tecar CAP electrode convex Ø 40 mm164672019-06-15

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