NRWClass II

Stimulator, Intramuscular, Automatic

21 CFR 880.5580 / General Hospital

NRW is the FDA product code for Stimulator, Intramuscular, Automatic, a class II device type, regulated under 21 CFR 880.5580. FDA's definition for this code reads: "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...". As of 2026-09-10, FDA records hold one 510(k) clearance under this code, the most recent dated 2004-08-26, and no recalls.

Classification record

Product code: NRW
Device name: Stimulator, Intramuscular, Automatic
FDA 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
Regulation: 21 CFR 880.5580
Device class: Class II
Review panel: General Hospital
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: Yes
Ingested clearances: 1
Ingested recalls: 0

Clearances, product code NRW

By decision year

1 clearance under product code NRW with a decision year between 2004 and 2004, 2004 the highest year at 1.

Show the numbers

510(k) clearances under FDA product code NRW by decision year
Year	Clearances
2004	1

Applicants with the most clearances

Product code NRW

Applicants holding the most 510(k) clearances under product code NRW
Applicant	Clearances
D.Y. Instrument, Inc.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code NRW.

Recent clearances

Product code NRW

K040580Class IIAis100 Automatic Intramuscular StimulatorD.Y. Instrument, Inc. / cleared 2004-08-26

Recent recalls

Product code NRW

FDA records show no recalls under product code NRW.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)