WINBACK

WINBACK GO EAST · Model BACK4 · UDI-DI 08800099100016

510(k) clearances

Adverse events

Recalls

Facilities

Description

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.

Recalls

Date	Firm	Reason
2017-07-13	Bios S.r.l.	In some systems, the unit continues to emit RF energy after the PAUSE button is pressed.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.