EXTRA TENS (RI-2500) NEO TENS (RI-2000E)— 510(k) K963507

Name: FDA 510(k) clearance K963507
Creator: U.S. Food and Drug Administration
Published: 1997-03-19

Substantially Equivalent

Comtek Intl., Corp.

FDA 510(k) clearance K963507 for EXTRA TENS (RI-2500) NEO TENS (RI-2000E), Substantially Equivalent on 1997-03-19. Applicant: Comtek Intl., Corp.. Device class: 2.

Clearance details

Applicant: Comtek Intl., Corp.
Product code: Code GZJ
Device class: Class 2
Regulation: 21 CFR 882.5890
Advisory panel: Neurology
Date received: 1996-09-03
Decision date: 1997-03-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Commack, NY, US

Download summary PDF View on FDA.gov ↗

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