483
Slow Wave, Inc.FDA 483 - Slow Wave, Inc.
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Record Details
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.
- Company
- Slow Wave, Inc.
- Product Type
- Device
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ID · 64f5a2c9-49eb-4686-93d2-cdcde5a05904