Cleared Traditional

TENS CARE, MODEL XL-Y3

K011543 · Tenscare, Ltd. · Neurology
Aug 2001
Decision
105d
Days
Class 2
Risk

About This 510(k) Submission

K011543 is an FDA 510(k) clearance for the TENS CARE, MODEL XL-Y3, 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 August 31, 2001, 105 days after receiving the submission on May 18, 2001. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5890.

Submission Details

510(k) Number K011543 FDA.gov
FDA Decision Cleared SESE
Date Received May 18, 2001
Decision Date August 31, 2001
Days to Decision 105 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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