FDA.reportPublic FDA data

GLOBUS

Primary DI
08032625821137
Brand
GLOBUS
Company
DOMINO SRL
Model
DIACARE 5500 PRO
Catalog number
G6457
Device description
The Diacare is a diathermy device that generates a high frequency sinusoidal current with a monopolar and bipolar mode of application using two electrodes. A fixed electrode is placed in contact with the patient and a hand-held electrode is manipulated by a therapist. When the electrode is in contact with a patient the electrical circuit is closed and RF therapy can be provided. The device can be operated in capacitive and resistive monopolar modes. T
Published
2024-09-04
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
K211207000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K211207000Diacare 7000Globus Sport and Health Technologies, LLC2022-06-06PBX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08032625821137PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08032625821137080326258211378032625821137

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
565257974
Device count
1
Serial number
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08032625824480GLOBUSG-WaveG80502026-02-23
08032625823315NerveOTXDX500G75702025-07-30
08032625822868GLOBUSVOLTA XG70962024-11-20
08032625822875GLOBUSARPneuroG71862024-11-20
08032625822882GLOBUSCIRCUIT BREAKERG69962024-11-20
08032625822851GLOBUSGENESY 3000G58822024-10-17
08032625824138GLOBUSPREMIUM FITNESSG10682024-10-17
08032625824183GLOBUSPREMIUM SPORT PLUSG20552024-10-17
08032625827535GLOBUSGOLF PROG51472024-10-17
08032625827566GLOBUSPREMIUM SPORTG10702024-10-17
08032625828037GLOBUSGLOBUS PHOENIX WAVEFORM ELITEG55272024-10-17
08032625829775GLOBUSRUNNER PROG66442024-10-17
08032625829782GLOBUSCYCLING PROG64532024-10-17
08032625829799GLOBUSAXON I MYO PROG31972024-10-17
08032625829805GLOBUSGLOBUS REVO STCG56012024-10-17
08032625829812GLOBUSGLOBUS REVO TO GOG55982024-10-17
08032625822837GLOBUSGENESY 600G69832024-09-04
08032625822844GLOBUSGENESY 1500G64672024-09-04
08032625825265GLOBUSGENESY 1100G20522024-09-04
08032625827528GLOBUSTRIATHLON PROG62652024-09-04

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