510(k) Report

510(k) · Cleared

Cleared

AIS100 Automatic Intramuscular Stimulator

K040580510(k) TraditionalCleared Aug 26, 2004175-day reviewClass II21 CFR 880.5580

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

D.Y. Instrument, Inc. · NRW Stimulator, Intramuscular, Automatic

Cleared on Aug 26, 2004 as substantially equivalent to K024207 (Helio Medical Supplies, Inc., 2003) after a 175-day review. Its family tree reaches back 1 generation to 2003.

Decided
Aug 26, 2004
Review
175 days
Class
Class II
Product code
NRW
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K024207 (2003). No later device cites it as a predicate yet.

Reference device: K973442 · Teca Disposable Monopolar Needle Electrodes · Medelec, Inc. D.B.A. Teca Corp. · 1997K024207 · Vinco Brand Acupuncture Needle · Helio Medical Supplies, Inc. · 20032000200220042006
K024207 · Vinco Brand Acupuncture Needle · Helio Medical Supplies, Inc. · 20030
  1. Root · 1 generation backK024207 Vinco Brand Acupuncture NeedleHelio Medical Supplies, Inc. · 2003
  2. This deviceK040580 AIS100 Automatic Intramuscular StimulatorD.Y. Instrument, Inc. · 2004
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K024207Vinco Brand Acupuncture NeedleHelio Medical Supplies, Inc.2003—
0 (this device)K040580AIS100 Automatic Intramuscular StimulatorD.Y. Instrument, Inc.2004—
FIG. 1 — Lineage of K040580, 2003–2004Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

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  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K024207Vinco Brand Acupuncture Needle
Summary page 1
…President Date Summary Prepared: May 30, 2004 2. Name of the Device: AIS1 00 Automatic Intramuscular Stimulator 3. Predicate Device Information: K024207, Vinco Brand Acupuncture Needle 4. Device Description: The AIS 100 is an intramuscular stimulator device that aids adminis…
Helio Medical Supplies, Inc.2003—
†K973442Teca Disposable Monopolar Needle ElectrodesMedelec, Inc. D.B.A. Teca Corp.1997—

Also cleared against K024207: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has no recall.
  • 1 other device also cites its predicate K024207.

How does its category compare?

All NRW devices

NRW Stimulator, Intramuscular, Automatic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · NRW

FDA has decided no NRW device since 2007.

Median 510(k) review, days · NRW

Too few NRW 510(k)s in any year since 2007 to give a median.

Recalls per year · NRW

No recall names NRW since 2007.

Adverse event reports per year · NRW

No MAUDE report names NRW since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

What is it indicated for?

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

Indications for use as stated in the FDA summary.

Also cleared against K024207

1 other device cites the same predicate.

  • K052731Kangsheng Brand/Kangnian Brand/Unilink Brand/Huazhong Brand Acupuncture NeedlesDaxin LI · 2006

https://510kreport.com/device/K040580 · printed Nov 4, 2026

Cite this page

510(k) Report. “K040580: AIS100 Automatic Intramuscular Stimulator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K040580

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026