FDA.reportPublic FDA data

Human Tecar

Primary DI
08056182721082
Brand
Human Tecar
Company
UNIBELL SRL
Model
Cylindrical Indifferent Electrode (Plastic connect
Catalog number
16930
Device description
Cylindrical Indifferent Electrode (Plastic connection)
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
08056182721082PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08056182721082080561827210828056182721082

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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06974223650141WinForthShenzhen Leaflife Technology Co., Ltd.PBX2026-04-22
07290016746402V-FR HandpieceVIORA LTDPBX2026-04-19
07290016746501V-FR TipVIORA LTDPBX2026-04-19
00810060832851Venus NovaVenus Concept Inc.PBX2026-04-15
00850055552494BellaTform ApplicatorInbella Medical IncPBX2026-04-02
00850055552180BellaPlus90 ApplicatorInbella Medical IncPBX2026-03-30
00850055552715i-BellaForma ApplicatorInbella Medical IncPBX2026-03-30
00850055552005BellaBodyFX ApplicatorInbella Medical IncPBX2026-03-26
00850055552036BellaForma ApplicatorInbella Medical IncPBX2026-03-26
00850055552043BellaPlus ApplicatorInbella Medical IncPBX2026-03-26
00850055552067BellaMiniFX ApplicatorInbella Medical IncPBX2026-03-26
00850055552470InBellaBody SystemInbella Medical IncPBX2026-03-25
00850055552555InBellaMax SystemInbella Medical IncPBX2026-03-25
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
08056182721327SUPERCHARGE HYDRA FASCIA ELECTRODES UNIBELL SRLPBX2026-03-16
08800092098013D20-RF0BDaeyang Medical Co., Ltd.PBX2026-03-10
04053915986880Tecarpuls IIZimmer MedizinSysteme GmbHPBX2026-02-12
07290016746563V-IPL Optic set Full 6 filtersVIORA LTDPBX2025-12-22
07290016814569PRO MAX, System, 110VENDYMED MEDICAL LTDPBX2025-11-17
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