Product code NRW— General Hospital

“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”

FDA has cleared 1 device under product code NRW, all in 2004, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

• D.Y. Instrument, Inc.1 clearance

• K040580 — AIS100 AUTOMATIC INTRAMUSCULAR STIMULATORD.Y. Instrument, Inc.·2004-08-26