Cleared Traditional

BESMED VARIOUS MODELS OF TENS, BE-550/BE-660

K031374 · Besmed Health Business Corp · Neurology
Nov 2003
Decision
212d
Days
Class 2
Risk

About This 510(k) Submission

K031374 is an FDA 510(k) clearance for the BESMED VARIOUS MODELS OF TENS, BE-550/BE-660, a Stimulator, Nerve, Transcutaneous, For Pain Relief (Class II — Special Controls, product code GZJ), submitted by Besmed Health Business Corp (Hsin Chu City, TW). The FDA issued a Cleared decision on November 28, 2003, 212 days after receiving the submission on April 30, 2003. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5890.

Submission Details

510(k) Number K031374 FDA.gov
FDA Decision Cleared SESE
Date Received April 30, 2003
Decision Date November 28, 2003
Days to Decision 212 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement

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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