Cleared Traditional

SIEMENS NEUROTON 826 AND 827 (K875238) - FDA 510(k) Clearance

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

K875238 · Elmed, Inc. · Physical Medicine device
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Mar 1988
Decision
79d
Days
Class 2
Risk

K875238 is an FDA 510(k) clearance for the SIEMENS NEUROTON 826 AND 827. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Elmed, Inc. (Addison, US). The FDA issued a Cleared decision on March 10, 1988 after a review of 79 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.

View all Elmed, Inc. devices

Submission Details

510(k) Number K875238 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 1987
Decision Date March 10, 1988
Days to Decision 79 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
36d faster than avg
Panel avg: 115d · This submission: 79d
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 73
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K875238.
SMITH & NEPHEW RESTIM
K003596 · Smith & Nephew, Inc. · Jun 2001
MUSCLEMAX ELECTRICAL MUSCLE STIMULATOR
K941049 · Smith & Nephew, Inc. · May 1994
MEDTRONIC RESPOND III NEUROMUSCULAR STIMULATOR
K920436 · Medtronic Vascular · May 1992
MYOCARE PLUS DUAL CHANNEL STIMULATOR
K851046 · 3M Company · Jul 1985
NEUROMEDICS ULTRASTIM 650-01
K841647 · Intermedics, Inc. · Jul 1984
NEUROMUSCULAR STIMULATOR 3105
K840467 · Medtronic Vascular · Feb 1984