Cleared Traditional

K832741 - JASON CERVICAL ORTHOSIS (FDA 510(k) Clearance)

Class I Physical Medicine device.

K832741 · Orthomedics · Physical Medicine device
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Sep 1983
Decision
36d
Days
Class 1
Risk

K832741 is an FDA 510(k) clearance for the JASON CERVICAL ORTHOSIS. Classified as Orthosis, Cervical-thoracic, Rigid (product code IQF), Class I - General Controls.

Submitted by Orthomedics (Mchenry, US). The FDA issued a Cleared decision on September 20, 1983 after a review of 36 days - a notably fast clearance cycle.

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: 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 Orthomedics devices

Submission Details

510(k) Number K832741 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 1983
Decision Date September 20, 1983
Days to Decision 36 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
79d faster than avg
Panel avg: 115d · This submission: 36d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code IQF Orthosis, Cervical-thoracic, Rigid
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.3490
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.