NRW · Class II — Moderate Risk (510(k) clearance required) · General Hospital · 21 CFR 880.5580
Classification
FDA Product Code
NRW
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 880.5580
Review panel
HO
Medical specialty
General Hospital
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
Y
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