Cleared Traditional

ULTIMA TENS XL-A1

K020846 · Tenscare, Ltd. · Neurology
May 2002
Decision
67d
Days
Class 2
Risk

About This 510(k) Submission

K020846 is an FDA 510(k) clearance for the ULTIMA TENS XL-A1, 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 May 21, 2002, 67 days after receiving the submission on March 15, 2002. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5890.

Submission Details

510(k) Number K020846 FDA.gov
FDA Decision Cleared SESE
Date Received March 15, 2002
Decision Date May 21, 2002
Days to Decision 67 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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