FDA.reportPublic FDA data

Human Tecar

Primary DI
08056182720870
Brand
Human Tecar
Company
UNIBELL SRL
Model
CAP electrode Ø 80 mm
Catalog number
16462
Device description
High-impedance CAP electrode, flat, thermodynamic Ø 80 mm
Published
2019-06-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
08056182720870PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08056182720870080561827208708056182720870

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
Lot or batch
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
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
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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Primary DI, Brand, Company table
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00850055552067BellaMiniFX ApplicatorInbella Medical IncPBX2026-03-26
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00850055552555InBellaMax SystemInbella Medical IncPBX2026-03-25
08056182720634SUPERCHARGE HYDRA FASCIA ELECTRODESUNIBELL SRLPBX2026-03-16
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08056182721167SUPERCHARGE HYDRA FASCIA ELECTRODESUNIBELL SRLPBX2026-03-16
08056182721174SUPERCHARGE HYDRA FASCIA ELECTRODESUNIBELL SRLPBX2026-03-16
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08056182721198SUPERCHARGE HYDRA FASCIA ELECTRODESUNIBELL SRLPBX2026-03-16
08056182721204SUPERCHARGE HYDRA FASCIA ELECTRODESUNIBELL SRLPBX2026-03-16
08056182721211SUPERCHARGE HYDRA FASCIA ELECTRODESUNIBELL SRLPBX2026-03-16
08056182721327SUPERCHARGE HYDRA FASCIA ELECTRODES UNIBELL SRLPBX2026-03-16
08800092098013D20-RF0BDaeyang Medical Co., Ltd.PBX2026-03-10
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