Cleared Traditional

K873125 - SOKEN(TM) ELECTRONIC MUSCLE STIMULATOR

K873125 is an FDA 510(k) clearance for SOKEN(TM) ELECTRONIC MUSCLE STIMULATOR, manufactured by Rehab Medical Specialties, Inc.. The device is a Class 2 Physical Medicine device with product code IPF cleared through the Traditional 510(k) pathway after a 143-day FDA review.

K873125 · Rehab Medical Specialties, Inc. · Physical Medicine device
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Dec 1987
Decision
143d
Days
Class 2
Risk

K873125 is an FDA 510(k) clearance for the SOKEN(TM) ELECTRONIC MUSCLE STIMULATOR. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Rehab Medical Specialties, Inc. (Garland, US). The FDA issued a Cleared decision on December 31, 1987 after a review of 143 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 Rehab Medical Specialties, Inc. devices

FDA 510(k) Submission Details - K873125

510(k) Number K873125 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 1987
Decision Date December 31, 1987
Days to Decision 143 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
28d slower than avg
Panel avg: 115d · This submission: 143d
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 258
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K873125.
INTELECT VMS 2, OR INTELECT VMS II
K880234 · Chattanooga Group, Inc. · Feb 1988
MODEL HL-100 PORTABLE DC ELECT. THERAPEUTIC UNIT
K871421 · Futuremed Div. of Future Impex Corp. · Jan 1988
RICH-MAR HV-2000 ELECTRICAL MUSCLE STIMULATOR
K874736 · Rich-Mar Corp. · Jan 1988
RICH-MAR CONDUCTIVE GEL
K872036 · Rich-Mar Corp. · Nov 1987
INTELECT 775
K872655 · Chattanooga Group, Inc. · Nov 1987
MYOSTIM(TM), MODEL 6600
K872753 · Medical Devices, Inc. · Oct 1987