Cleared Traditional

EVERLIFE POWERED MUSCLE STIMULATOR, MODEL E-100204, E-100504, E-100509, E-100804, E-201111, E-201211, E-201311 (K071320) - FDA 510(k) Clearance

Class II Physical Medicine device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K071320 · Everlife Medical Equipment Co., Ltd. · Physical Medicine device
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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

Submission Details

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.

Device Classification

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

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