Device product
KT RECOVERY+ ICE/HEAT MASSAGE BALL Rolling ball with hot and cold packs that can be interchanged depending on the therapy type desired
Z-1754-2020
Product summary
- Firm
- KT Health, LLC
- Event
- Event 85315
- Status
- Terminated
- Classification
- Class II
- Quantity
- 94,554
- Official record key
device-enforcement:Z-1754-2020
Official wording
Reason: If over-heated may leak which, if not noticed, may cause hot fluid to come in contact with the user.
Code information: UPC Codes: 814179022226 814179022561 814179022721
Distribution pattern: US Nationwide distribution, no Government Consignees.
Derived failure modes
-
Unknown
If over-heated may leak which, if not noticed, may cause hot fluid to come in contact with the user.