# FDA 483 - Electro Kinetic Technologies, LLC - February 15, 2019

Source: https://www.globalkeysolutions.net/records/483/electro-kinetic-technologies-llc/9a5be516-439a-4d55-aaae-d1d274acb7bc

> FDA 483 for Electro Kinetic Technologies, LLC on February 15, 2019. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Electro Kinetic Technologies, LLC
- Inspection Date: 2019-02-15
- Product Type: device
- Office Name: Minneapolis District Office
- Summary: An FDA inspection of Electro Kinetic Technologies, LLC in Germantown, WI, identified one observation related to device history records. The firm failed to include or refer to the location of a unique device identifier (UDI) or universal product code (UPC) in their device history records for a Class II patient transport chair. This indicates a deficiency in their UDI implementation for medical devices.

## Related Officers

- [Nicholas Z. Lu](https://www.globalkeysolutions.net/people/nicholas-z-lu/17448aca-e316-424c-b7b2-88c8baffc359)

Company: https://www.globalkeysolutions.net/companies/electro-kinetic-technologies-llc/a9582b99-3978-44d1-8e57-cbc54dc045d0

Office: https://www.globalkeysolutions.net/offices/minneapolis-district-office/c79fc8dc-f884-48fc-ba80-2947f662511d