510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K040580Substantially Equivalent

Ais100 Automatic Intramuscular Stimulator

D.Y. Instrument, Inc., Cherry Hill NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K040580 is the FDA 510(k) clearance record for AIS100 AUTOMATIC INTRAMUSCULAR STIMULATOR, a class II device, cleared for D.Y. Instrument, Inc. on under FDA product code NRW (Stimulator, Intramuscular, Automatic). FDA's definition for product code NRW 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...". FDA records list one 510(k) clearance for D.Y. Instrument, Inc. As of , FDA records show no recalls naming K040580.

Clearance record

Decision date
Received
(175 days to decision)
Product code
NRW Stimulator, Intramuscular, Automatic
Regulation
21 CFR 880.5580
Device class
Class II
Review panel
General Hospital
Applicant
D.Y. Instrument, Inc. 30 Manning Ln., Cherry Hill NJ
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NRW

Trailing 12 months

FDA records hold no clearances under product code NRW in the trailing twelve months.

FDA records show no clearances under product code NRW in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NRW, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260