AR1000 ULTRASONIC WOUND THERAPY SYSTEM— 510(k) K062544

Substantially Equivalent

Arobella Medical, LLC

FDA 510(k) clearance K062544 for AR1000 ULTRASONIC WOUND THERAPY SYSTEM, Substantially Equivalent on 2007-01-03. Applicant: Arobella Medical, LLC.

Clearance details

Applicant: Arobella Medical, LLC
Product code: Code LFL
Advisory panel: Unknown
Date received: 2006-08-30
Decision date: 2007-01-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carmel, IN, US

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Adverse events under product code LFL

product code LFL

Death: 29
Injury: 1,046
Malfunction: 21,642
Total: 22,717

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.