# FDA 483 - Xtreem Pulse LLC - October 13, 2023

Source: https://www.globalkeysolutions.net/records/483/xtreem-pulse-llc/9fb6a6c2-b3f3-452c-932f-ffb40b61e711

> FDA 483 for Xtreem Pulse LLC on October 13, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Xtreem Pulse LLC
- Inspection Date: 2023-10-13
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: An FDA inspection of Xtreem Pulse LLC in New York, NY, a manufacturer and specification developer of Class II transcutaneous electrical stimulator devices, revealed significant deficiencies in their quality system. Observations included the failure to establish a design history file, inadequate procedures for accepting incoming products, and insufficient procedures for managing design changes. These issues suggest a lack of proper controls over product design and manufacturing processes.

## Related Documents

- [483 - 2019-06-19](https://www.globalkeysolutions.net/records/483/xtreem-pulse-llc/b513a33c-fdae-4cd5-be9c-c851cb2ad233)
- [483 - 2022-06-29](https://www.globalkeysolutions.net/records/483/xtreem-pulse-llc/92d69a2d-bf6a-4d91-abd9-7ab8c39e3ea2)

## Related Officers

- [Colin E. Tack](https://www.globalkeysolutions.net/people/colin-e-tack/5bdbf977-d4ac-48fe-81cc-ada89379ed0d)

Company: https://www.globalkeysolutions.net/companies/xtreem-pulse-llc/4369da2f-f49e-455a-97cd-8b3efa71f387

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961