Cleared Traditional

K912642 - EMS300

K912642 is an FDA 510(k) clearance for EMS300, manufactured by Skylark Device Co., Ltd.. The device is a Class 2 Physical Medicine device with product code IPF cleared through the Traditional 510(k) pathway after a 178-day FDA review.

K912642 · Skylark Device Co., Ltd. · Physical Medicine device
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Dec 1991
Decision
178d
Days
Class 2
Risk

K912642 is an FDA 510(k) clearance for the EMS300, EMS400, EMS8000. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Skylark Device Co., Ltd. (Taipei, Taiwan, R.O.C., TW). The FDA issued a Cleared decision on December 9, 1991 after a review of 178 days - an extended review cycle.

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 Skylark Device Co., Ltd. devices

FDA 510(k) Submission Details - K912642

510(k) Number K912642 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 1991
Decision Date December 09, 1991
Days to Decision 178 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
63d slower than avg
Panel avg: 115d · This submission: 178d
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 171
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K912642.
RICH-MAR HV 1000 MUSCLE STIMULATOR
K920833 · Rich-Mar Corp. · May 1992
MEDTRONIC RESPOND III NEUROMUSCULAR STIMULATOR
K920436 · Medtronic Vascular · May 1992
RICH-MAR IFV 1000
K914539 · Rich-Mar Corp. · Dec 1991
REVISED HIGH VOLTAGE STIMULATOR INTELECT 150
K902599 · Chattanooga Group, Inc. · Oct 1990
RICH-MAR BP-2000 ELECTRICAL MUSCLE STIMULA. UNIT
K901779 · Rich-Mar Corp. · Jun 1990
SIEMENS STEREODYNATOR 828
K881431 · Elmed, Inc. · Apr 1990