Cleared Traditional

K012463 - LIFECARE 5*5 CM SQUARE, LIFECARE 4*4 CM SQUARE, LIFECARE 5 CM ROUND, LIFECARE 7.5 CM ROUND, LIFECARE 4*6 CM OVAL (FDA 510(k) Clearance)

K012463 · Everyway Medical Instruments Co.,Ltd · Neurology device
Feb 2002
Decision
188d
Days
Class 2
Risk

K012463 is an FDA 510(k) clearance for the LIFECARE 5*5 CM SQUARE, LIFECARE 4*4 CM SQUARE, LIFECARE 5 CM ROUND, LIFECARE 7.5 CM ROUND, LIFECARE 4*6 CM OVAL. This device is classified as a Electrode, Cutaneous (Class II - Special Controls, product code GXY).

Submitted by Everyway Medical Instruments Co.,Ltd (Shen Keng Hsiang,Taipei Hsien, TW). The FDA issued a Cleared decision on February 5, 2002, 188 days after receiving the submission on August 1, 2001.

This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1320.

Submission Details

510(k) Number K012463 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 2001
Decision Date February 05, 2002
Days to Decision 188 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement

Device Classification

Product Code GXY — Electrode, Cutaneous
Device Class Class II - Special Controls
CFR Regulation 21 CFR 882.1320