Cleared Traditional

TTS2500

K895166 · Henley Intl. · Neurology
Oct 1989
Decision
69d
Days
Class 2
Risk

About This 510(k) Submission

K895166 is an FDA 510(k) clearance for the TTS2500, a Stimulator, Nerve, Transcutaneous, For Pain Relief (Class II — Special Controls, product code GZJ), submitted by Henley Intl. (Sugar Land, US). The FDA issued a Cleared decision on October 30, 1989, 69 days after receiving the submission on August 22, 1989. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5890.

Submission Details

510(k) Number K895166 FDA.gov
FDA Decision Cleared SESE
Date Received August 22, 1989
Decision Date October 30, 1989
Days to Decision 69 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary —

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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