21 CFR §876.5340

1. (a)Identification. A nonimplanted nerve stimulator for functional abdominal pain relief is a device that stimulates nerves remotely from the source of pain with the intent to relieve functional abdominal pain. This generic type of device does not include devices designed to relieve pelvic pain.
2. (b)Classification. Class II (special controls). The special controls for this device are:
   1. (1)The patient-contacting components of the device must be demonstrated to be biocompatible.
   2. (2)Electromagnetic compatibility and electrical, mechanical, and thermal safety testing must be performed.
   3. (3)Electrical performance testing of the device and electrodes must be conducted to validate the specified electrical output and duration of stimulation of the device.
   4. (4)Software verification, validation, and hazard analysis must be performed.
   5. (5)Sterility testing of the percutaneous components of the device must be performed.
   6. (6)Shelf life testing must be performed to demonstrate continued sterility, package integrity, and device functionality over the labeled shelf life.
   7. (7)Labeling must include the following:
      1. (i)A detailed summary of the device technical parameters;
      2. (ii)A warning stating that the device is only for use on clean, intact skin;
      3. (iii)Instructions for use, including placement of the device on the patient; and
      4. (iv)A shelf life.