Cleared Traditional

K852264 - EBI FOOT MASSAGING PUMP

K852264 is an FDA 510(k) clearance for EBI FOOT MASSAGING PUMP, manufactured by Electro-Biology, Inc.. The device is a Class 2 Physical Medicine device with product code IRP cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K852264 · Electro-Biology, Inc. · Physical Medicine device
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Jul 1985
Decision
56d
Days
Class 2
Risk

K852264 is an FDA 510(k) clearance for the EBI FOOT MASSAGING PUMP. Classified as Massager, Powered Inflatable Tube (product code IRP), Class II - Special Controls.

Submitted by Electro-Biology, Inc. (Fairfield, US). The FDA issued a Cleared decision on July 19, 1985 after a review of 56 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Electro-Biology, Inc. devices

FDA 510(k) Submission Details - K852264

510(k) Number K852264 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 24, 1985
Decision Date July 19, 1985
Days to Decision 56 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 115d · This submission: 56d
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 98
Devices cleared under the same product code (IRP) and FDA review panel - the closest regulatory comparables to K852264.
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EBI HAND MASSAGING PUMP (HMP)
K860632 · Electro-Biology, Inc. · Apr 1986
INTERMITTENT COMPRESSION PUMPS
K832920 · Chattanooga Group, Inc. · Nov 1983