Cleared Traditional

K901931 - LEG EEZE

K901931 is an FDA 510(k) clearance for LEG EEZE, manufactured by Jereva, Inc.. The device is a Class 1 Physical Medicine device with product code IRO cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K901931 · Jereva, Inc. · Physical Medicine device
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Jun 1990
Decision
45d
Days
Class 1
Risk

K901931 is an FDA 510(k) clearance for the LEG EEZE. Classified as Vibrator, Therapeutic (product code IRO), Class I - General Controls.

Submitted by Jereva, Inc. (Sherman Oaks, US). The FDA issued a Cleared decision on June 14, 1990 after a review of 45 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5975 - 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 Jereva, Inc. devices

FDA 510(k) Submission Details - K901931

510(k) Number K901931 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 1990
Decision Date June 14, 1990
Days to Decision 45 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
70d faster than avg
Panel avg: 115d · This submission: 45d
Pathway characteristics
Predicate-based equivalence.

IRO Device Classification - Class 1, General Controls

Product Code IRO Vibrator, Therapeutic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.5975
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - IRO Vibrator, Therapeutic

All 22
Devices cleared under the same product code (IRO) and FDA review panel - the closest regulatory comparables to K901931.
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VIBRATOR
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