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UltraMIST Generator

ALLIQUA BIOMEDICAL, INC. · Model CP-80031 · UDI-DI 00816789010211

NRB Prescription

510(k) clearances

Adverse events (1 deaths)

Recalls

Facilities

Description

A portable assembly of mains electricity devices intended to deliver low frequency ultrasound energy via a fluid mist to a wound to promote healing of the wound without direct wound contact. The generator generates radio-frequency electrical energy which is subsequently transduced into ultrasound energy in the system treatment wand and pumps a fluid solution for the production of an ultrasound-conductive mist used to promote wound healing. The generator is intended to be used in conjunction with a system treatment wand and fluid source such as saline.

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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.