Recall Z-0176-2014— Pinook-Usa
Class II · Terminated
Class II FDA medical device recall by Pinook-Usa, initiated 2013-05-23, terminated 2016-09-29. FDA's recall record names no specific 510(k) clearance for this event. Product: Pinook Mini Massager Distributed by www.pinookusa.com. Used to strengthen the abdominal muscles.. Reason: Failure to submit a premarket submission and gain approval of a medical device..
- Recalling firm
- Pinook-Usa
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-05-23
- Terminated
- 2016-09-29
- Firm location
- Orlando, FL, United States
Product description
Pinook Mini Massager Distributed by www.pinookusa.com. Used to strengthen the abdominal muscles.
Reason for recall
Failure to submit a premarket submission and gain approval of a medical device.
Data sourced from openFDA. This site is unofficial and independent of the FDA.