# FDA 483 - Slow Wave, Inc. - Unknown Date

Source: https://www.globalkeysolutions.net/records/483/slow-wave-inc/64f5a2c9-49eb-4686-93d2-cdcde5a05904

> FDA 483 for Slow Wave, Inc. on Unknown Date. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Slow Wave, Inc.
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: 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.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/gilbert-valdez/9226d7ad-71e9-41b0-977e-8de133999b6a)

Company: https://www.globalkeysolutions.net/companies/slow-wave-inc/e6bf3b1f-319f-4484-8b89-57583995e583

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-iii/2cda09a5-06c4-433f-9df0-0d7903a6efab