| Device |
stimulator, intramuscular, automatic |
| Regulation Description |
Acupuncture needle. |
| Definition |
The automatic intramuscular stimulator is a device that aids muscle stimulation by using a method called dry needling for treatment.The device consists of a main control unit, a hand-held motor unit, and an ac power supply adapter.The motor unit has a mounted disposal syringe and a needle mounting hardware for a disposable needle, and enables the practitioner to administer treatment with less physical effort.An emg needle is used instead of an acupuncture needle because it is less flexible than the acupuncture needle. |
| Regulation Medical Specialty |
General Hospital |
| Review Panel |
General Hospital |
|---|
| Product Code | NRW |
|---|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
880.5580
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
| Third Party Review |
Not Third Party Eligible |
|
|
