WINBACK GO EAST Co Ltd

Matched from indexed company URL: WINBACK GO EAST

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
3016512343	3016512343	WINBACK GO EAST Co Ltd	1	N	2026-01-01	161, Usangongdan-Gil Wonju-si Gangwon KR 26335

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
239481	1315029032	K230167	BACK 4	IPF	2023-09-14
239481	1757612160	K230037	BACK 3	PBX	2023-07-19
239481	1303150719	K220014	RSHOCK	PBX	2023-03-01
239481	1400679986	K214090	Back 3 COLOR	PBX	2022-11-01
239481	1197413447	K162828	Winback Back 3SE	PBX	2017-09-18

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
PBX	4	2023-07-19
IPF	1	2023-09-14

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