FDA-Device2013-11-13Class II
Pinook Micro Massager Distributed by www.pinookusa.com Used to strengthen the abdominal muscles.
Pinook-Usa
Hazard
Failure to submit a premarket submission and gain approval of a medical device.
Sold states
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.
Affected count
28,994 units (Micro and Mini)
Manufactured in
901 Central Florida Pkwy Ste A6, N/A, Orlando, FL, United States
Products
Pinook Micro Massager Distributed by www.pinookusa.com Used to strengthen the abdominal muscles.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0177-2014Don't want to check this manually?
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