MODEL7500 MICROCURRENT TENS DEVICE, MCT-F5, MCT-F50, MCT-F500— 510(k) K013167

Name: FDA 510(k) clearance K013167
Creator: U.S. Food and Drug Administration
Published: 2002-01-30

Substantially Equivalent

Newcare Products, LLC

FDA 510(k) clearance K013167 for MODEL7500 MICROCURRENT TENS DEVICE, MCT-F5, MCT-F50, MCT-F500, Substantially Equivalent on 2002-01-30. Applicant: Newcare Products, LLC. Device class: 2.

Clearance details

Applicant: Newcare Products, LLC
Product code: Code GZJ
Device class: Class 2
Regulation: 21 CFR 882.5890
Advisory panel: Neurology
Date received: 2001-09-21
Decision date: 2002-01-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rockville, MD, US

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