Cleared Traditional

K953516 - MEDCOMP MC 5 GRADIENT SEQUENTIAL PUMP

K953516 is an FDA 510(k) clearance for MEDCOMP MC 5 GRADIENT SEQUENTIAL PUMP, manufactured by Yoav Gershoni. The device is a Class 2 Physical Medicine device with product code IRP cleared through the Traditional 510(k) pathway after a 135-day FDA review.

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

FDA 510(k) Submission Details - K953516

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.

IRP Device Classification - Class 2, Special Controls

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 132
Devices cleared under the same product code (IRP) and FDA review panel - the closest regulatory comparables to K953516.
ATLANT'S
K974395 · Grad-Line Corp. · Oct 1998
INTERMITTENT COMPRESSOR SYSTEM
K964957 · Eischoco, Inc. · Feb 1997
BIO BOOST
K961426 · Bio Compression Systems, Inc. · Oct 1996
FLOWTRON AC200/2
K874688 · Huntleigh Technology, Inc. · Sep 1988
EBI HAND MASSAGING PUMP (HMP)
K860632 · Electro-Biology, Inc. · Apr 1986
EBI FOOT MASSAGING PUMP
K852264 · Electro-Biology, Inc. · Jul 1985