Cleared Abbreviated

TENSCARE ITOUCH MODEL(S) EASY AND PLUS

K082377 · Tenscare, Ltd. · Neurology
Feb 2009
Decision
175d
Days
Class 2
Risk

About This 510(k) Submission

K082377 is an FDA 510(k) clearance for the TENSCARE ITOUCH MODEL(S) EASY AND PLUS, a Stimulator, Nerve, Transcutaneous, For Pain Relief (Class II — Special Controls, product code GZJ), submitted by Tenscare, Ltd. (Epsom, GB). The FDA issued a Cleared decision on February 9, 2009, 175 days after receiving the submission on August 18, 2008. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5890.

Submission Details

510(k) Number K082377 FDA.gov
FDA Decision Cleared SESE
Date Received August 18, 2008
Decision Date February 09, 2009
Days to Decision 175 days
Submission Type Abbreviated
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code GZJ — Stimulator, Nerve, Transcutaneous, For Pain Relief
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.5890

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