BACK3TX

GUDID 08800099100023

The BACK 3TX device generates high frequency sinusoidal current with a monopolar mode of application using two electrodes. A neutral electrode is placed in contact with the patient and a handheld active electrode is manipulated by a therapist. When both electrodes are in contact with a patient the electrical circuit is closed and RF therapy can be provided. The device can be operated in capacitive or resistive monopolar modes and a multipolar mode. The product consists of a power console, LCD monitor, and accessories including capacitive, resistive and multipolar electrodes. The unit can be adjusted to provide various levels of treatment frequency ranging from 300kHz to 1MHz. The product can also employ EMS technology. It generates a 4kHz or 1.5kHz electrostimulation signal (modulated at a frequency set between 2Hz and 200Hz). The two RF and EMS technologies should not be used in combination or sequentially. An emergency stop button feature allows the patient to shut down the unit in the event of any discomfort.

Winback Go East Co., Ltd.

Multi-modality physical therapy system, professional-use

• Primary Device ID: 08800099100023
• NIH Device Record Key: 995a755a-9876-4e03-9f6a-877553027e54
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BACK3TX
• Version Model Number: BACK3TX
• Company DUNS: 694959157
• Company Name: Winback Go East Co., Ltd.
• 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: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800099100023 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230037

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: 2025-07-24
• Device Publish Date: 2025-07-16

Devices Manufactured by Winback Go East Co., Ltd.

• 08800099100016 - BACK4: 2025-07-24 The BACK 4 device generates high frequency sinusoidal current with a monopolar mode of application using two electrodes. A neutr
• 08800099100023 - BACK3TX: 2025-07-24The BACK 3TX device generates high frequency sinusoidal current with a monopolar mode of application using two electrodes. A neutral electrode is placed in contact with the patient and a handheld active electrode is manipulated by a therapist. When both electrodes are in contact with a patient the electrical circuit is closed and RF therapy can be provided. The device can be operated in capacitive or resistive monopolar modes and a multipolar mode. The product consists of a power console, LCD monitor, and accessories including capacitive, resistive and multipolar electrodes. The unit can be adjusted to provide various levels of treatment frequency ranging from 300kHz to 1MHz. The product can also employ EMS technology. It generates a 4kHz or 1.5kHz electrostimulation signal (modulated at a frequency set between 2Hz and 200Hz). The two RF and EMS technologies should not be used in combination or sequentially. An emergency stop button feature allows the patient to shut down the unit in the event of any discomfort.
• 08800099100023 - BACK3TX: 2025-07-24 The BACK 3TX device generates high frequency sinusoidal current with a monopolar mode of application using two electrodes. A neu