FDA product code NRW: Stimulator, Intramuscular, Automatic
NRW is the FDA product code for stimulator, intramuscular, automatic. It is a Class II device, regulated under 21 CFR 880.5580 and reviewed by the General Hospital panel. FDA has cleared 1 510(k) submission under NRW. The average 510(k) review took 175 days (median 175).
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
Classification
| Field | Value |
|---|---|
| Device name | Stimulator, Intramuscular, Automatic |
| Device class | Class II |
| Regulation | 21 CFR 880.5580 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every NRW clearance
Top NRW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| D.Y. Instrument, Inc. | 1 | 2004-08-26 |
Most recent NRW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K040580 | D.Y. Instrument, Inc. | AIS100 AUTOMATIC INTRAMUSCULAR STIMULATOR | 2004-08-26 | 175 |
Recalls for NRW devices
openFDA lists no recalls for product code NRW.
Frequently asked questions
What is FDA product code NRW?
NRW is the FDA product code for stimulator, intramuscular, automatic. It is a Class II device, regulated under 21 CFR 880.5580 and reviewed by the General Hospital panel.
What device class is NRW?
Class II, regulation 21 CFR 880.5580. Typical premarket route: 510(k).
How long does a 510(k) take for product code NRW?
Across 1 cleared submissions the average was 175 days from receipt to decision (median 175).
Which companies have the most NRW clearances?
D.Y. Instrument, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code NRW
- Run a recall and safety report across every NRW manufacturer
- Watch product code NRW for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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