Device product
iTOVi Tracker/Scanner, Model Nos. ITS10 and ITS15 Intended to rank galvanic skin response measurements. The results are used by the software to generate a report that then makes a recommendation on nutritional supplements.
Z-2736-2018
Product summary
- Event
- Event 80483
- Status
- Terminated
- Classification
- Class II
- Quantity
- 35,949 units
- Official record key
device-enforcement:Z-2736-2018
Official wording
Reason: The device and its accessories may not have been manufactured according to current Good Manufacturing Practices. In addition, the firm has received three complaints regarding electric shocks received when using the device.
Code information: Device Lot/ Batch Numbers: 012016, 032016, 112016, 122016, 012017, 022017, 032017, 092017, 112017, 012018 Device Serial Numbers: 35,949 MAC Numbers ranging from 0F:72: D9:E9: F4:5A to FF: FF: AB:37: 7A:0C
Distribution pattern: Nationwide distribution. Worldwide distribution.
Derived failure modes
-
Unknown
The device and its accessories may not have been manufactured according to current Good Manufacturing Practices. In addition, the firm has received three complaints regarding electric shocks received when using the device.