Cleared Traditional

SUN-TENS PALM TYPE R5/COMPACT WIRELES M2 EMS SERIES (K011913) - FDA 510(k) Clearance

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

K011913 · Sun-Rain System Corp. · Physical Medicine device
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Oct 2001
Decision
129d
Days
Class 2
Risk

K011913 is an FDA 510(k) clearance for the SUN-TENS PALM TYPE R5/COMPACT WIRELES M2 EMS SERIES. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Sun-Rain System Corp. (Hsin-Chu City, TW). The FDA issued a Cleared decision on October 26, 2001 after a review of 129 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 Sun-Rain System Corp. devices

Submission Details

510(k) Number K011913 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 2001
Decision Date October 26, 2001
Days to Decision 129 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
14d slower than avg
Panel avg: 115d · This submission: 129d
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

All 546
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