NRW

1 FDA 510(k) clearances · Product code

FDA profile

Official device name

Stimulator, Intramuscular, Automatic

Device class

Class II (moderate risk)

Regulation

21 CFR 880.5580

Medical specialty

General Hospital

Flags

Third-party review eligible

FDA 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

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