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 |