medical Class II Updated 2020-09-09

Stimwave Technologies Inc recalls StimQ Peripheral Nerve Stimulator System (PNS) Models: 1. F

Recalled Product

StimQ Peripheral Nerve Stimulator System (PNS) Models: 1. FR4A-RCV-AO US and 2. FR4A-RCV-A0 EU - Product Usage: is used for peripheral neural stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The therapy utilizes pulsed electrical current to create an electrical energy field that acts on peripheral nerves in the limbs and torso to alter the transmission of pain signals to the brain.


Hazard / Issue

The product contains a non-functional component not referenced in product labeling.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: 1. FR4A-RCV-A0 US, Serial Numbers: 210426-88, 210426-89, 210426-90, 210426-91, 210426-92, 210426-93; 2. FR4A-RCV-A0 EU, Serial Numbers: 210425-19, 210425-22, 210425-23, 210425-6, 210425-63, 210425-64, 210425-7.
View official government recall

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