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510(k) Data Aggregation
K Number
K040580Device Name
AIS100 AUTOMATIC INTRAMUSCULAR STIMULATOR
Manufacturer
Date Cleared
2004-08-26
(175 days)
Product Code
Regulation Number
880.5580Why did this record match?
Product Code :
NRW
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The DY 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
Device Description
The AIS 100 is an intramuscular stimulator device that aids administering of intramuscular stimulation (or dry needling) for treatment. The device produces an automated forward and backward motion of a needle at a constant speed, which replaces the manual stroking of a needle when rendering the intramuscular stimulation (or dry needling) treatment. This enables the practitioner to administer the intramuscular stimulation treatment effectively with less physical effort when compared to the manual method. The device consists of a main control unit, a hand-held motor unit, and an AC power supply adapter.
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