TENSCARE ITOUCH MODEL(S) EASY AND PLUS— 510(k) K082377

Name: FDA 510(k) clearance K082377
Creator: U.S. Food and Drug Administration
Published: 2009-02-09

Substantially Equivalent

Tenscare, Ltd.

FDA 510(k) clearance K082377 for TENSCARE ITOUCH MODEL(S) EASY AND PLUS, Substantially Equivalent on 2009-02-09. Applicant: Tenscare, Ltd.. Device class: 2.

Clearance details

Applicant: Tenscare, Ltd.
Product code: Code GZJ
Device class: Class 2
Regulation: 21 CFR 882.5890
Advisory panel: Neurology
Date received: 2008-08-18
Decision date: 2009-02-09
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Epsom, GB

Download summary PDF View on FDA.gov ↗

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