PAIN DOC
Device Facts
| Record ID | K941342 |
|---|---|
| Device Name | PAIN DOC |
| Applicant | Regulatory & Marketing Services, Inc. |
| Product Code | GZB · Neurology |
| Decision Date | Oct 13, 1995 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 882.5880 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An implanted spinal cord stimulator for pain relief is a device that is used to stimulate electrically a patient's spinal cord to relieve severe intractable pain. The stimulator consists of an implanted receiver with electrodes that are placed on the patient's spinal cord and an external transmitter for transmitting the stimulating pulses across the patient's skin to the implanted receiver.
