Cleared Traditional

K893903 - KRONAMAX KUBE

K893903 is an FDA 510(k) clearance for KRONAMAX KUBE, manufactured by Physicians Digital Co.. The device is a Class 1 Neurology device with product code KQX cleared through the Traditional 510(k) pathway after a 183-day FDA review.

K893903 · Physicians Digital Co. · Neurology device
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Nov 1989
Decision
183d
Days
Class 1
Risk

K893903 is an FDA 510(k) clearance for the KRONAMAX KUBE. Classified as Goniometer, Ac-powered (product code KQX), Class I - General Controls.

Submitted by Physicians Digital Co. (Richmond, US). The FDA issued a Cleared decision on November 29, 1989 after a review of 183 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 888.1500 - the FDA neurology 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 Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Physicians Digital Co. devices

FDA 510(k) Submission Details - K893903

510(k) Number K893903 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 30, 1989
Decision Date November 29, 1989
Days to Decision 183 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d slower than avg
Panel avg: 148d · This submission: 183d
Pathway characteristics
Predicate-based equivalence.

KQX Device Classification - Class 1, General Controls

Product Code KQX Goniometer, Ac-powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 888.1500
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 - KQX Goniometer, Ac-powered

All 10
Devices cleared under the same product code (KQX) and FDA review panel - the closest regulatory comparables to K893903.
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