Device product
Volt Resistance Heated Slipper (All sizes) Deep penetrating heat garment and wraps
Z-1812-2017
Product summary
- Event
- Event 76787
- Status
- Terminated
- Classification
- Class II
- Quantity
- 22,757 items in total
- Official record key
device-enforcement:Z-1812-2017
Official wording
Reason: During an FDA inspection it was found that the firm claims unapproved therapy and medical claims on product information and website.
Code information: Item #VS-FB
Distribution pattern: Nationwide Distribution
Derived failure modes
-
Unknown
During an FDA inspection it was found that the firm claims unapproved therapy and medical claims on product information and website.