510(k) K040580
K040580 is an FDA 510(k) premarket notification submitted by D.Y. Instrument, Inc. for the device "AIS100 AUTOMATIC INTRAMUSCULAR STIMULATOR". The FDA issued a decision of Substantially Equivalent on August 26, 2004. The device falls under product code NRW (Stimulator, Intramuscular, Automatic), a Class II device regulated under 21 CFR 880.5580.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 26, 2004
- Date Received
- March 4, 2004
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stimulator, Intramuscular, Automatic
- Device Class
- Class II
- Regulation Number
- 880.5580
- Review Panel
- HO
- Submission Type
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