Cleared Traditional

K953516 - MEDCOMP MC 5 GRADIENT SEQUENTIAL PUMP (FDA 510(k) Clearance)

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

K953516 · Yoav Gershoni · Physical Medicine device
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Dec 1995
Decision
135d
Days
Class 2
Risk

K953516 is an FDA 510(k) clearance for the MEDCOMP MC 5 GRADIENT SEQUENTIAL PUMP. Classified as Massager, Powered Inflatable Tube (product code IRP), Class II - Special Controls.

Submitted by Yoav Gershoni (Gaithersburg, US). The FDA issued a Cleared decision on December 8, 1995 after a review of 135 days - within the typical 510(k) review window.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5650 - 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 Yoav Gershoni devices

Submission Details

510(k) Number K953516 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received July 26, 1995
Decision Date December 08, 1995
Days to Decision 135 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
20d slower than avg
Panel avg: 115d · This submission: 135d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IRP Massager, Powered Inflatable Tube
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5650
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 - IRP Massager, Powered Inflatable Tube

All 151
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