| Device |
transcutaneous electrical spine stimulator to improve skeletal muscle strength and sensation |
| Definition |
A transcutaneous electrical spine stimulator to improve skeletal muscle strength and sensation is a device that can be programmed to apply an electrical current via electrodes on a patient's skin over the spine to improve muscle strength and sensation after neurological deficit. |
| Physical State |
A transcutaneous electrical spine stimulator includes a stimulator that can set or receive stimulation parameters and send that to electrodes to be placed externally over the spine. |
| Technical Method |
A stimulator generates and delivers electrical stimulation to the intended area through stimulation electrodes. |
| Target Area |
Patient's skin over the spine |
| Regulation Medical Specialty |
Physical Medicine |
| Review Panel |
Physical Medicine |
|---|
| Product Code | SDO |
|---|
| Premarket Review |
Office of Neurological and Physical Medicine Devices
(OHT5)
Neuromodulation and Physical Medicine Devices
(DHT5B)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
890.5851
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Ineligible |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Third Party Review |
Not Third Party Eligible |
