Cleared Traditional

AIS100 AUTOMATIC INTRAMUSCULAR STIMULATOR (K040580) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K040580 · D.Y. Instrument, Inc. · General Hospital
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Aug 2004
Decision
175d
Days
Class 2
Risk

K040580 is an FDA 510(k) clearance for the AIS100 AUTOMATIC INTRAMUSCULAR STIMULATOR. Classified as Stimulator, Intramuscular, Automatic (product code NRW), Class II - Special Controls.

Submitted by D.Y. Instrument, Inc. (Cherry Hill, US). The FDA issued a Cleared decision on August 26, 2004 after a review of 175 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5580 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all D.Y. Instrument, Inc. devices

Submission Details

510(k) Number K040580 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 2004
Decision Date August 26, 2004
Days to Decision 175 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
46d slower than avg
Panel avg: 129d · This submission: 175d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NRW Stimulator, Intramuscular, Automatic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5580
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
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.