Cleared Traditional

K071320 - EVERLIFE POWERED MUSCLE STIMULATOR, MODEL E-100204, E-100504, E-100509, E-100804, E-201111, E-201211, E-201311

K071320 is an FDA 510(k) clearance for EVERLIFE POWERED MUSCLE STIMULATOR, manufactured by Everlife Medical Equipment Co., Ltd.. The device is a Class 2 Physical Medicine device with product code IPF cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K071320 · Everlife Medical Equipment Co., Ltd. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2007
Decision
99d
Days
Class 2
Risk

K071320 is an FDA 510(k) clearance for the EVERLIFE POWERED MUSCLE STIMULATOR, MODEL E-100204, E-100504, E-100509, E-100.... Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Everlife Medical Equipment Co., Ltd. (Hsin-Chu City, TW). The FDA issued a Cleared decision on August 17, 2007 after a review of 99 days - within the typical 510(k) review window.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5850 - the FDA physical medicine 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 Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Everlife Medical Equipment Co., Ltd. devices

FDA 510(k) Submission Details - K071320

510(k) Number K071320 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 2007
Decision Date August 17, 2007
Days to Decision 99 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
16d faster than avg
Panel avg: 115d · This submission: 99d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IPF Device Classification - Class 2, Special Controls

Product Code IPF Stimulator, Muscle, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5850
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 Physical Medicine devices follow this clearance model.

Regulatory Peers - IPF Stimulator, Muscle, Powered

All 208
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K071320.
KNEEHAB XP CONTROLLER, MODEL 411
K092791 · Bio-Medical Research, Ltd. · Dec 2009
MAXEMS, MODELS 1000 AND 2000
K091248 · Bio Protech, Inc. · Nov 2009
KNEEHAB XP CONDUCTIVE GARMENT, TYPE 411
K083105 · Bio-Medical Research, Ltd. · Jul 2009
VECTRA GENISYS VMS FR
K062354 · Encore Medical, L.P. · Jan 2007
MYOTRAC INFINITI
K053266 · Thought Technology , Ltd. · Dec 2005
NEUROTECH KNEEHAB
K024258 · Bio-Medical Research, Ltd. · Mar 2005