Title 21: Food and Drugs
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/ PART 882 - NEUROLOGICAL DEVICES
/ Subpart F - Neurological Therapeutic Devices / § 882.5870 Implanted peripheral nerve stimulator for pain relief.
§ 882.5870 Implanted peripheral nerve stimulator for pain relief.
(a) Identification. An implanted peripheral nerve stimulator for pain relief is a device that is used to stimulate electrically a peripheral nerve in a patient to relieve severe intractable pain. The stimulator consists of an implanted receiver with electrodes that are placed around a peripheral nerve and an external transmitter for transmitting the stimulating pulses across the patient's skin to the implanted receiver.
(b) Classification. Class II (performance standards).