# FDA 483 - Healthtronics, Inc. - May 13, 2022

Source: https://www.keypedia.com/records/483/healthtronics-inc/5c0c5ff1-d382-492d-954d-c4e175ae602c

> FDA 483 for Healthtronics, Inc. on May 13, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Healthtronics, Inc.
- Inspection Date: 2022-05-13
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: An FDA inspection of Healthtronics, Inc. in Austin, TX, a medical device manufacturer, revealed significant deficiencies in its design control procedures. The firm failed to establish procedures for design validation and design changes for its TwinTrode electrode. Specifically, Healthtronics could not provide documentation to support claims of increased longevity for the TwinTrode device.

## Related Officers

- [Jocelyn C. Turner](https://www.keypedia.com/people/jocelyn-c-turner/7e39f6e0-9750-4460-8a4e-27ee9306b77e)

Company: https://www.keypedia.com/companies/healthtronics-inc/34f44bda-20e4-4bc1-83a7-0e5069909814

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