Cleared Traditional

K760547 - STIMULATOR

K760547 is the FDA 510(k) clearance for STIMULATOR by R. A. Fischer Co. Corp.. It is a Class 2 Physical Medicine device (product code IPF) cleared through the Traditional 510(k) pathway after a 171-day FDA review.

K760547 · R. A. Fischer Co. Corp. · Physical Medicine device
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Feb 1977
Decision
171d
Days
Class 2
Risk

K760547 is an FDA 510(k) clearance for the STIMULATOR, ELECTRICAL MUSCLE (#MD-4). Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by R. A. Fischer Co. Corp. (Mchenry, US). The FDA issued a Cleared decision on February 17, 1977 after a review of 171 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 R. A. Fischer Co. Corp. devices

Submission Details

510(k) Number K760547 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 1976
Decision Date February 17, 1977
Days to Decision 171 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
56d slower than avg
Panel avg: 115d · This submission: 171d
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.