Cleared Traditional

K851037 - ORTHOTRON MUSCLE STIMULATOR MK II DC

K851037 is the FDA 510(k) clearance for ORTHOTRON MUSCLE STIMULATOR MK II DC by Hodgkinson & Corby , Ltd.. It is a Class 2 Physical Medicine device (product code IPF) cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K851037 · Hodgkinson & Corby , Ltd. · Physical Medicine device
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Jun 1985
Decision
97d
Days
Class 2
Risk

K851037 is an FDA 510(k) clearance for the ORTHOTRON MUSCLE STIMULATOR MK II DC. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Hodgkinson & Corby , Ltd. (Henley-On-Thames/England, GB). The FDA issued a Cleared decision on June 19, 1985 after a review of 97 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 Hodgkinson & Corby , Ltd. devices

Submission Details

510(k) Number K851037 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received March 14, 1985
Decision Date June 19, 1985
Days to Decision 97 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
18d faster than avg
Panel avg: 115d · This submission: 97d
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 153
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K851037.
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K850013 · Mettler Electronics Corp. · Apr 1985
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K844617 · Excel Tech. , Ltd. · Mar 1985