FDA.reportPublic FDA data

Doctor Tecar

Primary DI
08051499970161
Brand
Doctor Tecar
Company
MECTRONIC MEDICALE SRL
Model
Doctor Tecar
Device description
Doctor Tecar is a diathermy product. This therapy increases the temperature in the body areas under treatment by means of a particular electric current, restoring the natural reparative capacity of the body. The dual delivery modes, capacitive and resistive, allow setting a specific treatment based on the disease to be cured, thus regenerating the tissues in depth.
Published
2021-11-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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
K183693000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K183693000Doctor TecarMectronic Medicale S.R.L.2019-02-22PBX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08051499970161PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08051499970161080514999701618051499970161

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

Contacts#

Phone, Email table
PhoneEmail
+39035656080info@mectronicmedicale.it

Regulatory Flags#

DUNS number
429098838
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08051499970864Doctor Tecar Plus0.87_N2021-11-07
08051499971007CHELT F EB 601CTFEB602024-11-28
08051499974084iLux LF D121LFD122024-11-28
08051499974107iLux LF D251LFD252024-11-28
08051499970758Ixyon XP F50 ED1IXF50ED2024-10-10
08051499970765Ixyon XP F92 OA1IXF92OA2024-10-10
08051499971304iLux LF Y101LFY102024-10-10
08051499971328iLux LF HPS Y151LFHY152024-10-10
08051499971335iLux LF HPS D101LFHD102024-10-10
08051499971342iLux LF Y151LFY152024-10-10
08051499971359iLux LF HPS D301LFHD302024-10-10
08051499971366iLux LF HPS V101LFHV102024-10-10
08051499971373iLux LF HPS Y101LFHY102024-10-10
08051499971403iLux LF HPS R21LFHR22024-10-10
08051499971410iLux LF HPS V151LFHV152024-10-10
08051499971427iLux LF HPS V201LFHV202024-10-10
08051499971434iLux LF HPS D151LFHD152024-10-10
08051499971441iLux LF HPS D201LFHD202024-10-10
08051499971458iLux LF HPS V301LFHV302024-10-10
08051499971489iLux LF HPS T301LFHT302024-10-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06974223650141WinForthShenzhen Leaflife Technology Co., Ltd.PBX2026-04-22
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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