Cleared Traditional

K834092 - MULTIPLE SOKEN 3 ELECTRON-MUSCLE STIM

K834092 is an FDA 510(k) clearance for MULTIPLE SOKEN 3 ELECTRON-MUSCLE STIM, 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 22-day FDA review.

K834092 · Rehab Medical Specialties, Inc. · Physical Medicine device
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Dec 1983
Decision
22d
Days
Class 2
Risk

K834092 is an FDA 510(k) clearance for the MULTIPLE SOKEN 3 ELECTRON-MUSCLE STIM. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Rehab Medical Specialties, Inc. (Walker, US). The FDA issued a Cleared decision on December 20, 1983 after a review of 22 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K834092

510(k) Number K834092 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 28, 1983
Decision Date December 20, 1983
Days to Decision 22 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
94d faster than avg
Panel avg: 116d · This submission: 22d
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 544
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K834092.
BMR POWERSTIM
K840149 · Bio-Medical Research Corp. · Jan 1984
BIONICARE STIMULATOR BIO-1
K832805 · Murray Electronics · Dec 1983
COSMODYN-S INTERFERENTIAL MUSCLE STIM
K833945 · Leo Unlimited, Inc. · Dec 1983
NUTRA-TONE 500
K833808 · Applied Optic Kinetics , Ltd. · Dec 1983
BX-600 EMS
K832976 · Bloomex International, Inc. · Nov 1983
STAODYN EMS/PLUS
K832988 · Staodynamics, Inc. · Nov 1983
K834092 · MULTIPLE SOKEN 3 ELECTRON-MUSCLE STIM
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