FDA.report

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 | 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
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
08056182721327PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08056182721327080561827213278056182721327

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
false
Serial number
true
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

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

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
08056182720634SUPERCHARGE HYDRA FASCIA ELECTRODESUNIBELL SRLPBX2026-03-16
08056182721143SUPERCHARGE HYDRA FASCIA ELECTRODESUNIBELL SRLPBX2026-03-16
08056182721167SUPERCHARGE HYDRA FASCIA ELECTRODESUNIBELL SRLPBX2026-03-16
08056182721174SUPERCHARGE HYDRA FASCIA ELECTRODESUNIBELL SRLPBX2026-03-16
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
08800092098013D20-RF0BDaeyang Medical Co., Ltd.PBX2026-03-10
08034108513270ONDA PRODEKA M.E.L.A. SRLPBX2025-11-17
08034108513263body ESTIQDEKA M.E.L.A. SRLPBX2025-09-26
07290016746785V-FC Pro FullVIORA LTDPBX2025-09-01
07290016746808V-FC Pro TipVIORA LTDPBX2025-09-01
07290016746815V-FC Pro HandpieceVIORA LTDPBX2025-09-01
05391540830857Préime DermaFacial EMA AESTHETICS LIMITEDPBX2025-08-07
08800099100146Hi-TENSWINBACK GO EASTPBX2025-07-23
08800099100016BACK4Winback Go East Co., Ltd.PBX2025-07-16
08800099100023BACK3TXWinback Go East Co., Ltd.PBX2025-07-16
08800016905083Wav12CLASSYS Inc.PBX2025-07-02
08800016905106Wav50CLASSYS Inc.PBX2025-07-02
08800016905175QUADESSY Wavplus hand pieceCLASSYS Inc.PBX2025-07-02
D650WONDER1Wonder Touch XOD Inc.PBX2025-07-01
08800092099010TENSAMAX PRO+Daeyang Medical Co., Ltd.PBX2025-06-20
07290016746464V-ST Single Use tipVIORA LTDPBX2025-06-03
07290016746471V-VR HandpieceVIORA LTDPBX2025-06-03
17290016746652V-FC TipVIORA LTDPBX2025-05-22
00860013508609MIRARI Cold Plasma unit box setGeneral Vibronics, LLCPBX2025-04-30
00860013508616MIRARI Cold Plasma DriverGeneral Vibronics, LLCPBX2025-04-30
00860013508623MIRARI Cold Plasma System Insulating Fleece PouchGeneral Vibronics, LLCPBX2025-04-30
00860013508630MIRARI Cold Plasma System ArrayGeneral Vibronics, LLCPBX2025-04-30