# K040580: AIS100 Automatic Intramuscular Stimulator

- Pathway: 510(k) (Traditional)
- Applicant: D.Y. Instrument, Inc.
- Decided: Aug 26, 2004 after 175 days
- Product code: NRW (Stimulator, Intramuscular, Automatic)
- Device class: 2
- Regulation: 21 CFR 880.5580
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K024207 (2003). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K024207: Vinco Brand Acupuncture Needle, Helio Medical Supplies, Inc. (2003) Summary page 1.

## Indications for use
The D.Y. Instrument, Inc. AIS100 Automatic Intramuscular Stimulator Device is intended, as part of a treatment regimen, for 1. Intramuscular stimulation 2. Symptomatic relief of tension-type headache of myofascial origin

Source page: https://510kreport.com/device/K040580
Methodology: https://510kreport.com/methodology