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Stimulator, Intramuscular, Automatic

FDA product code NRW · 1 cleared devices

Class 2 General Hospital
Regulation
21 CFR 880.5580
Review panel
HO
Implant
No
Life sustaining
No
Third party review
Yes
GMP exempt
No
Clearance span
2004-08-26 – 2004-08-26

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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