Cleared Traditional

K850453 - SINUS AC-POWERED MUSCLE STIMULATOR

K850453 is the FDA 510(k) clearance for SINUS AC-POWERED MUSCLE STIMULATOR by Zimmer Elektromedizin GmbH. It is a Class 2 Physical Medicine device (product code IPF) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K850453 · Zimmer Elektromedizin GmbH · Physical Medicine device
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May 1985
Decision
90d
Days
Class 2
Risk

K850453 is an FDA 510(k) clearance for the SINUS AC-POWERED MUSCLE STIMULATOR. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Zimmer Elektromedizin GmbH (7910 Neu-Ulm, Germany, DE). The FDA issued a Cleared decision on May 7, 1985 after a review of 90 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 Zimmer Elektromedizin GmbH devices

Submission Details

510(k) Number K850453 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 1985
Decision Date May 07, 1985
Days to Decision 90 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
25d faster than avg
Panel avg: 115d · This submission: 90d
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 150
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K850453.
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