Device product
Pinook Mini Massager Distributed by www.pinookusa.com. Used to strengthen the abdominal muscles.
Z-0176-2014
Product summary
- Firm
- Pinook-Usa
- Event
- Event 66191
- Status
- Terminated
- Classification
- Class II
- Quantity
- 28,994 units (Mini and Micro)
- Official record key
device-enforcement:Z-0176-2014
Official wording
Reason: Failure to submit a premarket submission and gain approval of a medical device.
Code information: ALL LOTS
Distribution pattern: Worldwide Distribution-USA (nationwide) including Puerto Rico and Guam and the states of AZ, CA, CO, FL, IL, MA, MD, MO, MT, NC, ND, NJ, NV, NY, TX, VA, and WA and the country of Canada.
Derived failure modes
-
Unknown
Failure to submit a premarket submission and gain approval of a medical device.