Cleared Traditional

K770509 - TABLE, MASSAGE AND TREATMENT (FDA 510(k) Clearance)

Class I Physical Medicine device.

K770509 · Will Ross Co. · Physical Medicine device
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Apr 1977
Decision
19d
Days
Class 1
Risk

K770509 is an FDA 510(k) clearance for the TABLE, MASSAGE AND TREATMENT. Classified as Plinth (product code INT), Class I - General Controls.

Submitted by Will Ross Co. (Mchenry, US). The FDA issued a Cleared decision on April 5, 1977 after a review of 19 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3520 - 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 Will Ross Co. devices

Submission Details

510(k) Number K770509 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 1977
Decision Date April 05, 1977
Days to Decision 19 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
96d faster than avg
Panel avg: 115d · This submission: 19d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code INT Plinth
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.3520
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.