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UltraMIST Treatment Wand

ALLIQUA BIOMEDICAL, INC. · Model CP-80033 · UDI-DI 00816789010204

NRB Prescription

510(k) clearances

Adverse events (1 deaths)

Recalls

Facilities

Description

A hand-held mains electricity electronic component of a wound therapy ultrasound system intended to convert (transduce) electrical energy into low frequency ultrasound energy for application to a wound site via a fluid mist to promote wound healing. It is a non-contact device which may include a display / controls, intended to connect proximally to the system generator and distally to a disposable applicator. It is used in conjunction with a fluid source such as saline with the ultrasound-conductive mist directed at the wound site for removal of fibrin, yellow slough, tissue exudates, and bacteria.

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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.