FDA-Device2014-07-02Class II

IF 8000; 1/F Interferential Electrical Stimulation Device; NMES (neuromuscular electrical stimulation) mode. Designed for use in physical therapy, rehabilitation, and pain relief applications.

Zynex Medical, Inc.
Hazard

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.

Sold states
Nationwide Distribution
Affected count
1,461
Manufactured in
9990 Park Meadows Dr, N/A, Lone Tree, CO, United States
Products
IF 8000; 1/F Interferential Electrical Stimulation Device; NMES (neuromuscular electrical stimulation) mode. Designed for use in physical therapy, rehabilitation, and pain relief applications.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1874-2014

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