NRW — Stimulator, Intramuscular, Automatic Class II
FDA product code NRW covers "Stimulator, Intramuscular, Automatic", a Class II medical device regulated under 21 CFR 880.5580. Submissions are reviewed by the General Hospital panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- NRW
- Device Class
- Class II
- Regulation Number
- 880.5580
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General Hospital
- Implant
- No
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
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K040580 | d.y. instrument | AIS100 AUTOMATIC INTRAMUSCULAR STIMULATOR | August 26, 2004 |