Cleared Traditional

K951228 - ASH-7000

K951228 is an FDA 510(k) clearance for ASH-7000, manufactured by U.S. Table, Inc.. The device is a Class 2 Physical Medicine device with product code ITH cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K951228 · U.S. Table, Inc. · Physical Medicine device
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May 1995
Decision
58d
Days
Class 2
Risk

K951228 is an FDA 510(k) clearance for the ASH-7000. Classified as Equipment, Traction, Powered (product code ITH), Class II - Special Controls.

Submitted by U.S. Table, Inc. (Glen Allen, US). The FDA issued a Cleared decision on May 17, 1995 after a review of 58 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5900 - 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 U.S. Table, Inc. devices

FDA 510(k) Submission Details - K951228

510(k) Number K951228 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 1995
Decision Date May 17, 1995
Days to Decision 58 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
57d faster than avg
Panel avg: 115d · This submission: 58d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ITH Device Classification - Class 2, Special Controls

Product Code ITH Equipment, Traction, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5900
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Physical Medicine devices follow this clearance model.

Regulatory Peers - ITH Equipment, Traction, Powered

All 35
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