Cleared Traditional

K933418 - HAND THERAPY ASSOST

K933418 is an FDA 510(k) clearance for HAND THERAPY ASSOST, manufactured by Bardon Ent., Inc.. The device is a Class 1 Physical Medicine device with product code JFA cleared through the Traditional 510(k) pathway after a 289-day FDA review.

K933418 · Bardon Ent., Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1994
Decision
289d
Days
Class 1
Risk

K933418 is an FDA 510(k) clearance for the HAND THERAPY ASSOST. Classified as Exerciser, Finger, Powered (product code JFA), Class I - General Controls.

Submitted by Bardon Ent., Inc. (Hampton, US). The FDA issued a Cleared decision on April 28, 1994 after a review of 289 days - an extended review cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5410 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Bardon Ent., Inc. devices

FDA 510(k) Submission Details - K933418

510(k) Number K933418 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 13, 1993
Decision Date April 28, 1994
Days to Decision 289 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
174d slower than avg
Panel avg: 115d · This submission: 289d
Pathway characteristics
Predicate-based equivalence.

JFA Device Classification - Class 1, General Controls

Product Code JFA Exerciser, Finger, Powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.5410
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.