Cleared Traditional

K071624 - EVERELIFE TRANSCUTANEOUS MUSCLE STIMULATOR

K071624 is an FDA 510(k) clearance for EVERELIFE TRANSCUTANEOUS MUSCLE STIMULATOR, manufactured by Everlife Medical Equipment Co., Ltd.. The device is a Class 2 Neurology device with product code GZJ cleared through the Traditional 510(k) pathway after a 166-day FDA review.

K071624 · Everlife Medical Equipment Co., Ltd. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2007
Decision
166d
Days
Class 2
Risk

K071624 is an FDA 510(k) clearance for the EVERELIFE TRANSCUTANEOUS MUSCLE STIMULATOR. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Everlife Medical Equipment Co., Ltd. (Hsin-Chu City, TW). The FDA issued a Cleared decision on November 27, 2007 after a review of 166 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5890 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K071624

510(k) Number K071624 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 2007
Decision Date November 27, 2007
Days to Decision 166 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
17d slower than avg
Panel avg: 149d · This submission: 166d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GZJ Device Classification - Class 2, Special Controls

Product Code GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5890
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief

All 541
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K071624.
PROSTIM 1000/2000
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HOMEWAVE NEUROMODULATIONS PAIN THERAPY DEVICE
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DELTA SCANNER, DELTA SCANNER PRO, DS SPINE PRO, DS SPORTS PRO AND DS REHAB
K071878 · Med-Lectric Corporation · Dec 2007
NEURO WAVE 6
K062003 · Lhasa Oms, Inc. · Sep 2007
COMFY SERIES: EV-804, EV-805 & EV-806
K071951 · Everyway Medical Instruments Co.,Ltd · Sep 2007
LORENZ BIOTECH APTIVA, VERSION 2.13
K061828 · Lorenz Biotech S.P.A. · Aug 2007
K071624 · EVERELIFE TRANSCUTANEOUS MUSCLE STIMULATOR
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