FDA.report

SUPERCHARGE HYDRA FASCIA ELECTRODES

Primary DI
08056182720634
Brand
SUPERCHARGE HYDRA FASCIA ELECTRODES
Company
UNIBELL SRL
Model
Structuranova Ø 65 mm
Catalog number
17682
Device description
Structuranova Ø 65 mm, thickness 25 mm, is a capacitive electrode designed specifically for the HCR1002 medical device.
Published
2026-03-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
PBXMassager, Vacuum, Radio Frequency Induced Heat

Product Code Classifications

CodeDeviceSpecialtyClass
PBXMassager, Vacuum, Radio Frequency Induced HeatGeneral, Plastic Surgery2

Premarket Submissions

SubmissionSupplement
K181211000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K181211000Human Tecar HCR 1002Unibell S.R.L2018-09-10PBX

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08056182720634PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08056182720634080561827206348056182720634

GMDN Terms

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

Regulatory Flags

DUNS number
338736462
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

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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
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08056182721211SUPERCHARGE HYDRA FASCIA ELECTRODESStructuranova Ø 90 mm 177352026-03-16
08056182721327SUPERCHARGE HYDRA FASCIA ELECTRODES 165682026-03-16
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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08056182721181SUPERCHARGE HYDRA FASCIA ELECTRODESUNIBELL SRLPBX2026-03-16
08056182721198SUPERCHARGE HYDRA FASCIA ELECTRODESUNIBELL SRLPBX2026-03-16
08056182721204SUPERCHARGE HYDRA FASCIA ELECTRODESUNIBELL SRLPBX2026-03-16
08056182721211SUPERCHARGE HYDRA FASCIA ELECTRODESUNIBELL SRLPBX2026-03-16
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