
Arobella Medical, LLC
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AS 1000 ULTRASOUND WOUND THERAPY SYSTEM is an FDA 510(k)-cleared medical device (K091038) manufactured by Arobella Medical, LLC. This device is classified under the General, Plastic Surgery specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 18, 2009. Regulation: 8.