WINBACK

WINBACK GO EAST · Model Hi-TENS · UDI-DI 08800099100146

510(k) clearances

Adverse events

Recalls

Facilities

Description

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.

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.