Cleared Traditional

MODIFICATION TO RELIEF BRIEF (K003128) - FDA 510(k) Clearance

Class I Physical Medicine device.

K003128 · The JM Kohn Co. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2002
Decision
675d
Days
Class 1
Risk

K003128 is an FDA 510(k) clearance for the MODIFICATION TO RELIEF BRIEF. Classified as Orthosis, Truncal, For Dysmenorrhea (product code NJB), Class I - General Controls.

Submitted by The JM Kohn Co. (San Francisco, US). The FDA issued a Cleared decision on August 12, 2002 after a review of 675 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3490 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Physical Medicine submissions.

View all The JM Kohn Co. devices

Submission Details

510(k) Number K003128 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 06, 2000
Decision Date August 12, 2002
Days to Decision 675 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
560d slower than avg
Panel avg: 115d · This submission: 675d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code NJB Orthosis, Truncal, For Dysmenorrhea
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.3490
Definition A Truncal Orthosis For Dysmenorrhea Is A Device Intended To Provide Pressure To Acupressure Points On The Lower Abdomen And Lower Back For The Purpose Of Reducing Menstrual Pain Symptoms Including Cramps, Abdominal Pain And Backache.
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.