Cleared Traditional

K830289 - PDB II

K830289 is an FDA 510(k) clearance for PDB II, manufactured by J.A. Gerber Therapeutical, Ltd.. The device is a Class 1 Physical Medicine device with product code INQ cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K830289 · J.A. Gerber Therapeutical, Ltd. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1983
Decision
57d
Days
Class 1
Risk

K830289 is an FDA 510(k) clearance for the PDB II. Classified as Table, Powered (product code INQ), Class I - General Controls.

Submitted by J.A. Gerber Therapeutical, Ltd. (Mchenry, US). The FDA issued a Cleared decision on March 25, 1983 after a review of 57 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3760 - 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.

FDA 510(k) Submission Details - K830289

510(k) Number K830289 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 1983
Decision Date March 25, 1983
Days to Decision 57 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
59d faster than avg
Panel avg: 116d · This submission: 57d
Pathway characteristics
Predicate-based equivalence.

INQ Device Classification - Class 1, General Controls

Product Code INQ Table, Powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.3760
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 - INQ Table, Powered

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K830289 · PDB II
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