Cleared Traditional

TENSCARE, MODEL TENS XL-2

K003591 · Tenscare, Ltd. · Neurology
Feb 2001
Decision
85d
Days
Class 2
Risk

About This 510(k) Submission

K003591 is an FDA 510(k) clearance for the TENSCARE, MODEL TENS XL-2, a Stimulator, Nerve, Transcutaneous, For Pain Relief (Class II — Special Controls, product code GZJ), submitted by Tenscare, Ltd. (Timperley, Cheshire, GB). The FDA issued a Cleared decision on February 14, 2001, 85 days after receiving the submission on November 21, 2000. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5890.

Submission Details

510(k) Number K003591 FDA.gov
FDA Decision Cleared SESE
Date Received November 21, 2000
Decision Date February 14, 2001
Days to Decision 85 days
Submission Type Traditional
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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