FDA.reportPublic FDA data

GLOBUS

Primary DI
08032625821120
Brand
GLOBUS
Company
DOMINO SRL
Model
DIACARE 8000 PRO
Catalog number
G6458
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.
Published
2026-09-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
08032625821120PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08032625821120080326258211208032625821120

Regulatory Flags#

DUNS number
565257974
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08032625821137GLOBUSDIACARE 5500 PROG64572024-09-04
08032625822837GLOBUSGENESY 600G69832024-09-04
08032625822844GLOBUSGENESY 1500G64672024-09-04
08032625825265GLOBUSGENESY 1100G20522024-09-04
08032625827528GLOBUSTRIATHLON PROG62652024-09-04
08032625827559GLOBUSSOCCER PROG62662024-09-04
08032625828020GLOBUSGLOBUS PHOENIX WAVEFORM PROG55292024-09-04
08032625829843NerveOTXDX1000 PROG49172026-07-28
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809932290075NeoSculpt PlusS&M Medical Co., Ltd.PBX2026-10-20
B108499AP1MRA1MUS00Large applicatorBTL INDUSTRIES LIMITEDPBX2026-10-20
B108499AP1MRA2MUS00Small applicatorBTL INDUSTRIES LIMITEDPBX2026-10-20
B108499AP1MRA45MUS00Edge applicatorsBTL INDUSTRIES LIMITEDPBX2026-10-20
B108499PO1MUS00BTL-499-1BTL INDUSTRIES LIMITEDPBX2026-10-20
B108890APMMUS00EMFACE controllerBTL INDUSTRIES LIMITEDPBX2026-10-12
08809932290082NeoSculpt PlusS&M Medical Co., Ltd.PBX2026-10-09
08809932290099NeoSculpt PlusS&M Medical Co., Ltd.PBX2026-10-09
08809932290105NeoSculpt PlusS&M Medical Co., Ltd.PBX2026-10-09
08809932290112NeoSculpt PlusS&M Medical Co., Ltd.PBX2026-10-09
08809932290129NeoSculpt PlusS&M Medical Co., Ltd.PBX2026-10-09
08809932290136NeoSculpt PlusS&M Medical Co., Ltd.PBX2026-10-09
08809932290143NeoSculpt PlusS&M Medical Co., Ltd.PBX2026-10-09
00872320007218SveltivaCAO GROUP, INC.PBX2026-10-01
B108890POAMUS00BTL-890UBTL INDUSTRIES LIMITEDPBX2026-08-26
08809851470145WavefacialWEERO Co., Ltd.PBX2026-06-22
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