SCRAMBLER ST 5 TENS DEVICE— 510(k) K081255

Name: FDA 510(k) clearance K081255
Creator: U.S. Food and Drug Administration
Published: 2009-02-20

Substantially Equivalent

Competitive Technologies,Inc.

FDA 510(k) clearance K081255 for SCRAMBLER ST 5 TENS DEVICE, Substantially Equivalent on 2009-02-20. Applicant: Competitive Technologies,Inc.. Device class: 2.

Clearance details

Applicant: Competitive Technologies,Inc.
Product code: Code GZJ
Device class: Class 2
Regulation: 21 CFR 882.5890
Advisory panel: Neurology
Date received: 2008-05-02
Decision date: 2009-02-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Attleboro, MA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.