GLOBUS G6457

GUDID 08032625821137

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

DOMINO SRL

Medium-wave diathermy treatment system

• Primary Device ID: 08032625821137
• NIH Device Record Key: 477b7286-3401-43df-8c06-6ba1814663c6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GLOBUS
• Version Model Number: DIACARE 5500 PRO
• Catalog Number: G6457
• Company DUNS: 565257974
• Company Name: DOMINO SRL
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08032625821137 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211207

FDA Product Code

• PBX: Massager, Vacuum, Radio Frequency Induced Heat

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-09-12
• Device Publish Date: 2024-09-04

On-Brand Devices [GLOBUS]

• 08032625828020: The Globus Genesy Device is a programmable electro stimulator with multiple uses: Powered Muscl
• 08032625827559: The Globus Premium Sport and Fitness Devices are programmable muscle stimulators. Each device in
• 08032625827528: The Globus Premium Sport and Fitness Devices are programmable muscle stimulators. Each device in
• 08032625825265: The Globus Genesy Device is a programmable electro stimulator with multiple uses: Powered Muscl
• 08032625822844: The Globus Genesy Device is a programmable electro stimulator with multiple uses: Powered Muscl
• 08032625822837: The Globus Genesy Device is a programmable electro stimulator with multiple uses: Powered Muscl
• 08032625821137: The Diacare is a diathermy device that generates a high frequency sinusoidal current with a mono
• 08032625829812: The Globus Device is a programmable electro stimulator with multiple uses: Powered Muscle Stimu
• 08032625829805: The Globus Device is a programmable electro stimulator with multiple uses: Powered Muscle Stimu
• 08032625829799: The Globus Device is a programmable electro stimulator with multiple uses: Powered Muscle Stimu
• 08032625829782: The Globus Premium Sport and Fitness Devices are programmable muscle stimulators. Each device in
• 08032625829775: The Globus Premium Sport and Fitness Devices are programmable muscle stimulators. Each device in
• 08032625828037: The Globus Device is a programmable electro stimulator with multiple uses: Powered Muscle Stimu
• 08032625827566: The Globus Premium Sport and Fitness Devices are programmable muscle stimulators. Each device in
• 08032625827535: The Globus Premium Sport and Fitness Devices are programmable muscle stimulators. Each device in
• 08032625824183: The Globus Premium Sport and Fitness Devices are programmable muscle stimulators. Each device in
• 08032625824138: The Globus Premium Sport and Fitness Devices are programmable muscle stimulators. Each device in
• 08032625822851: The Globus Device is a programmable electro stimulator with multiple uses: Powered Muscle Stimu
• 08032625822882: The Globus Circuit Breaker Device is a programmable electro stimulator with multiple uses: Powe
• 08032625822875: The Globus ARPneuro device is a programmable electro stimulator with multiple uses: Powered Mus
• 08032625822868: The Globus Volta X device is a programmable electro stimulator with multiple uses: Powered Musc