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WINBACK GO EAST Co Ltd

Matched from indexed company URL: WINBACK GO EAST

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30165123433016512343WINBACK GO EAST Co Ltd1N2026-01-01161, Usangongdan-Gil Wonju-si Gangwon KR 26335

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2394811315029032K230167BACK 4IPF2023-09-14
2394811757612160K230037BACK 3PBX2023-07-19
2394811303150719K220014RSHOCKPBX2023-03-01
2394811400679986K214090Back 3 COLORPBX2022-11-01
2394811197413447K162828Winback Back 3SEPBX2017-09-18

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
PBX42023-07-19
IPF12023-09-14

GUDID#

WINBACK - The Hi-TENS device generates a 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 and 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 a resistive monopolar mode. The product consists of a power console, LCD monitor, and accessories including resistive electrodes. The unit can provide one level of treatment frequency at 300kHz. Electrodes are attached with an active cable that plugs in on the lateral side of the unit. A safety switch feature allows the patient to shut down the unit in the event of any discomfort.

WINBACK GO EAST

2025-07-23

WINBACK - The BACK 4 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

2025-07-16

WINBACK - 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

2025-07-16