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510(k) Data Aggregation
K Number
K013167Device Name
MODEL7500 MICROCURRENT TENS DEVICE, MCT-F5, MCT-F50, MCT-F500
Manufacturer
NEWCARE PRODUCTS, LLC.
Date Cleared
2002-01-30
(131 days)
Product Code
GZJ
Regulation Number
882.5890Why did this record match?
Applicant Name (Manufacturer) :
NEWCARE PRODUCTS, LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Model 7500 Microcurrent TENS Device is intended to be used for the relief of chronic intractable pain.
Device Description
A number of TENS and microcurrent devices have been cleared for marketing by FDA that have just a few discrete output settings, rather than having a continuously adjustable output. Such devices have been shrinking in size in recent years as advances in integrated circuits and other components allow for smaller circuits. Now NewCare Products is introducing a microcurrent TENS device that has the generator unit builtin to the back of the electrodes. By eliminating the bulky controls, the generator may be made very small and can be mounted on the electrode pad.
By providing three versions of the device, three different output levels The three versions of the Model 7500 are equivalent to are obtained. one traditional generator with three discrete output levels.
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