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510(k) Data Aggregation
K Number
K960457Device Name
ELECTRONIC MUSCLE STIMULATOR MODEL EMS-1C/EMS-2C
Manufacturer
MED LABS, INC.
Date Cleared
1996-09-06
(220 days)
Product Code
IPF
Regulation Number
890.5850Why did this record match?
Applicant Name (Manufacturer) :
MED LABS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Not Found
Device Description
The new versions will incorporate three changes, all of which we believe to be minor, and may be accurately described as technological improvements.
1. First, we wish to change the type of battery from a 67.5 volt to a 9 volt.
2. Second, we are changing the electrode connectors from .080" pin plugs and pin jacks to a safer design as recommended by the F.D.A.. The new connector will be a 3.5mm right angle phone plug, which is physically too large to fit into a standard 120 volt outlet.
3. The third change will add a new circuit to limit the on-time (Pulse Width) and duty cycle in the Interrupted D.C. (Galvanic) mode.
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