Recall Z-1874-2014— Zynex Medical, Inc.
Class II · Terminated
Class II FDA medical device recall by Zynex Medical, Inc., initiated 2009-01-25, terminated 2015-07-02. It names one FDA 510(k) clearance: K991241. Product: IF 8000; 1/F Interferential Electrical Stimulation Device; NMES (neuromuscular electrical stimulation) mode. Designed for use in physical therapy, rehabilitation, and pain relief applications.. Reason: Zynex notified customers that a malfunction in the IF 8000 can result in the device ceasing to operate, and in some instances,overheating and becoming hot to the touch..
- Recalling firm
- Zynex Medical, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2009-01-25
- Terminated
- 2015-07-02
- Firm location
- Lone Tree, CO, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
IF 8000; 1/F Interferential Electrical Stimulation Device; NMES (neuromuscular electrical stimulation) mode. Designed for use in physical therapy, rehabilitation, and pain relief applications.
Reason for recall
Zynex notified customers that a malfunction in the IF 8000 can result in the device ceasing to operate, and in some instances,overheating and becoming hot to the touch.
Data sourced from openFDA. This site is unofficial and independent of the FDA.