FDA 483 - Slow Wave, Inc.

An FDA inspection of Slow Wave, Inc. in Marble Falls, TX, conducted from May 1-3, 2023, revealed two significant observations. The firm failed to establish and document schedules for equipment maintenance and was found to be non-compliant with Unique Device Identification (UDI) requirements for its Class II Slow Wave DS8 device. These issues indicate deficiencies in the firm's quality system and regulatory adherence.