FDA.reportPublic FDA data

INDIBA DEEP CARE - EVONY

Primary DI
08434251003084
Brand
INDIBA DEEP CARE - EVONY
Company
INDIBA SA.
Model
IDC0409
Catalog number
IDC0409USA
Device description
Radiofrequency devices. Electrosurgical cutting and coagulation device and accessories. The Indiba Evony device is intended to provide topical heating for the purpose of elevating tissue temperature for treatment of selected medical conditions.
Published
2025-02-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
K241107000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K241107000Indiba Diathermia Radiofrequency Deep Care Device (Deep care IDC0409/EVONY ); Indiba Diathermia Radiofrequency Activ Device (Activ ACT0309/CT9)Indiba S. A. U.2025-01-24PBX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08434251003084PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08434251003084084342510030848434251003084

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
460060916
Device count
1
Serial number
true
Manufacturing date on label
true
Donation ID number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08434251004173REVERSO PRO SYSTEMIDC0410IDC0410USA2025-07-31
08434251003640INDIBA ACTIV - ACTIV CT9ACT0309ACT0309BLKUSA2025-02-06
08434251000229INDIBA ACTIV - CT9ACT0309USAACT0309USA2019-02-06
08434251004791COMPACT LITEACT0507ACT0507USA2025-01-29
08434251004814COMPACT PLUSACT0508ACT0508USA2025-01-29
08434251004838COMPACT PROACT0509ACT0509USA2025-01-29
18434251002718INDIBA DEEP CARE - REVERSO - Tip 88 pinsACC1015REVERSO tip 88 pins2023-06-05
18434251002725INDIBA DEEP CARE - REVERSO - Tip 176 pinsACC1017REVERSO tip 176 pins2023-06-05
18434251002831INDIBA DEEP CARE - REVERSO - Tip 44 pinsACC1013REVERSO tip 44 pins2023-06-05
08434251002636INDIBA DEEP CARE - REVERSOIDC0400USAREVERSO2023-06-05
08434251002667INDIBA DEEP CARE - REVERSO - Applicator handleACC1018USAREVERSO applicator handle2023-06-05
18434251002640INDIBA DEEP CARE - REVERSO - Tip 80 pinsACC1014USAREVERSO tip 80 pins2023-06-05
18434251002657INDIBA DEEP CARE - REVERSO - Tip 160 pinsACC1016USAREVERSO tip 160 pins2023-06-05
08434251000915INDIBA ACTIV - AT7ACT0407USAAT72021-04-06
08434251000014INDIBA ACTIV - ACTIV 902ACT229ACT2292019-02-22
08434251000021INDIBA ACTIV - ACTIV 801ACT228ACT2282019-02-22
08434251000038INDIBA ACTIV - ACTIV 701ACT227ACT2272019-02-22
08434251000045INDIBA DEEP CARE - ELITEIDC0077IDC00772019-02-22
08434251000052INDIBA DEEP CARE - PREMIUMIDC0076IDC00762019-02-22
08434251000236INDIBA ACTIV - CT8ACT0308USAACT0308USA2019-02-22

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