Cleared Traditional

K011913 - SUN-TENS PALM TYPE R5/COMPACT WIRELES M2 EMS SERIES

K011913 is an FDA 510(k) clearance for SUN-TENS PALM TYPE R5/COMPACT WIRELES M..., manufactured by Sun-Rain System Corp.. The device is a Class 2 Physical Medicine device with product code IPF cleared through the Traditional 510(k) pathway after a 129-day FDA review.

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

FDA 510(k) Submission Details - K011913

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.

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 197
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K011913.
300 PV COMPLETE ELECTROTHERAPY SYSTEM
K021100 · Empi · Jun 2002
MODIFICATION TO: WINNER ST-2 STIMULATOR
K013770 · Rich-Mar Corp. · Jan 2002
MODIFICATION TO: WINNER CM-2 MUSCLE STIMULATOR, TENS, THERAPEUTIC ULTRASOUND AND COMBINATION DEVICE
K013771 · Rich-Mar Corp. · Jan 2002
ELECTRO NEUROMUSCULAR STIMULATOR, MODEL NMS-DIGITAL
K010749 · Biomedical Life Systems, Inc. · Sep 2001
AEMS V, EMS-1000, MODEL TS-140500 AND AEMS VI, EMS-1000 PLUS, MODEL TS-140600
K002339 · Apex Medical Corp. · Aug 2001
MS104A, NEWMINI II (EMS-II), MODEL AP-101050T AND MEDTRIM (EMS-V), MODEL AP-102050T
K002336 · Apex Medical Corp. · Jul 2001